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Набира участници Фаза 2/3

Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial

Extensive Stage Lung Small Cell Carcinoma

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

Начало: 07.01.2021 Край: 30.04.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04402788

Набира участници Фаза 1/2

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

B Cell Precursor Acute Lymphoblastic Leukemia

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

Начало: 04.01.2021 Край: 25.05.2029 Възраст: от 12 г. Лечение

Argentina, Australia, Austria +16 Amgen NCT04521231

Набира участници

Study on the Diagnostic Efficacy of ICL Selection and Prediction Depth Model Based on Eye Images

Posterior Chamber Phakic Intraocular Lens Vault Deep Neural Network Myopia +1

To evaluate the diagnostic efficacy of deep learning network model in implantable collamer lens selection and prediction in a multicenter cross-sectional study

Начало: 02.01.2021 Край: 31.08.2027 Възраст: 18–45 г.

China Second Affiliated Hospital of Nanchang University NCT06669728

Набира участници Фаза 3

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

Advanced Lung Non-Squamous Non-Small Cell Carcinoma Metastatic Lung Non-Squamous Non-Small Cell Carcinoma Recurrent Lung Non-Squamous Non-Small Cell Carcinoma Stage IIIB Lung Cancer AJCC v8 +1

This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.

Начало: 28.12.2020 Край: 31.12.2026 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04181060

Набира участници

Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis

Gastric Cancer Gastric Neoplasm Gastrointestinal Stromal Sarcoma Gastrointestinal Stromal Neoplasm +1

Objective: To follow people with GISTs and collect tumor tissue so that it can be studied in the lab. Eligibility: People age 6 and older who have a GIST. Design: Participants will be screened with a review of their medical records and samples. Participants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies. Participants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained. Participants may speak with a genetic counselor. They may have genetic testing. Participants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek. Participants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis. Participants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery. If a participant has surgery, tumor tissue samples and research specimen will be taken. If a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.

Начало: 18.12.2020 Край: 30.12.2040 Възраст: от 6 г.

United States National Cancer Institute (NCI) NCT04557969

Набира участници Фаза 2

Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Solid Tumor

This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment. 45 patients will be randomized into the following arms: * Arm A (standard): relaxation with music listening during radiotherapy treatment * Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment For the study each patient will be followed during 2 months.

Начало: 07.12.2020 Край: 01.08.2027 Възраст: от 18 г.

France Institut Claudius Regaud NCT04513444

Набира участници

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

Cervical Carcinoma Endometrial Carcinoma Endometriosis Pelvic Inflammatory Disease

This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.

Начало: 04.12.2020 Край: 15.10.2028 Възраст: от 18 г.

United States Mayo Clinic NCT04567771

Набира участници Фаза 1/2

Oral Metformin for Treatment of ABCA4 Retinopathy

ABCA4 Retinopathy Stargardt Disease Retinal Dystrophy Retinal Degeneration

Background: ABCA4 retinopathy is a genetic disease in which the ABCA4 protein is absent or faulty. It can cause waste material to collect in the eye and may cause cells to die. The cell death can lead to vision loss. Researchers want to see if an oral drug called metformin can help. Objective: To see if metformin is safe and possibly helps to slow the rate of ABCA4 retinopathy. Eligibility: People age 12 and older who have ABCA4 retinopathy and have problems with their vision. Design: Participants will be screened under a separate protocol. Participants will have a medical and family history. They will complete a questionnaire about their vision and daily activities. They will have a physical exam. They may have blood drawn through a needle in the arm. Participants will have an eye exam. Their pupils may be dilated with eye drops. Their retina may be photographed. Participants will have a visual field test. They will sit in front of a large dome and press a button when they see a light within the dome. Participants will have an electroretinogram. It examines the function of the retina. They will sit in the dark for 30 minutes. Then their eyes will be numbed with eye drops. They will wear contact lenses that can sense signals from the retinas. They will watch flashing lights. Participants will have optical coherence tomography. This non-invasive procedure makes pictures of the retina. Participants will have fundus autofluorescence. A bright blue light will be shone into their eye. Participants will take metformin by mouth for 24 months. Participants will have study visits every 6 months. Participation will last for at least 36 months....

Начало: 23.11.2020 Край: 30.09.2028 Възраст: 12–100 г.

United States National Eye Institute (NEI) NCT04545736

Набира участници Фаза 1/2

Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

Ischemia Reperfusion Injury Delayed Graft Function

The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.

Начало: 13.11.2020 Край: 30.06.2028 Възраст: 18–75 г.

United States Rhode Island Hospital NCT04005469

Набира участници Фаза 2

Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.

Primary CNS Lymphoma

* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment. * The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration * Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone. * However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half. * Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).

Начало: 02.11.2020 Край: 02.11.2028 Възраст: от 19 г.

South Korea Kim, Seok Jin NCT04627753

Набира участници

Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

Lumbar Disc Disease

To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.

Начало: 01.11.2020 Край: 28.12.2029 Възраст: 18–50 г.

Spain University of Valencia NCT04641039

Набира участници Фаза 1/2

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

Advanced Liver Cancers

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

Начало: 01.11.2020 Край: 30.09.2027 Възраст: от 18 г. Лечение

China, France, Israel +4 Hoffmann-La Roche NCT04524871

Набира участници Фаза 1

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

Advanced Solid Tumors Metastatic Pancreatic Cancer Pediatric Solid Tumor Advanced Breast Cancer +2

Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: * blood tests * physical exam * documentation of disease confirmation or tumor biopsy * electrocardiogram to evaluate the heart * review of their medicines and their ability to do their normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.

Начало: 27.10.2020 Край: 31.12.2028 Възраст: 12–120 г.

United States National Cancer Institute (NCI) NCT04222413

Набира участници

Thoracoabdominal Asynchrony and Respiratory Distress

Respiratory Insufficiency

The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions. AIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.

Начало: 16.10.2020 Край: 01.06.2026 Възраст: 28–17 г.

United States Massachusetts General Hospital NCT04626154

Набира участници Фаза 1/2

Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy

Metastatic Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Lymph Nodes Stage IVB Prostate Cancer AJCC v8

This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.

Начало: 14.10.2020 Край: 30.04.2026 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04071236

Набира участници Фаза 1/2

Clinical Trials of Multivalent Opioid Vaccine Components

Opioid-use Disorder

Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study is designed to examine a new approach to treating OUD, namely use of a vaccine targeted against oxycodone \[Oxy(Gly)4-sKLH\], one of the most commonly abused prescription opioids. The vaccination approach to treating substance use disorders relies on the ability of the vaccine to produce antibodies that bind the target drug in blood and reduce its ability to enter the brain. The long-term goal of this research will be to develop a combined vaccine against oxycodone and heroin. However, in this trial the Oxy(Gly)4-sKLH vaccine will be studied separately. This is a multi-site study, being conducted at the New York State Psychiatric Institute and the Clinilabs clinical research unit (CRU) in Eatontown, New Jersey. The current study proposes to evaluate safety (Aim 1), degree of antibody production (Aim 2), and efficacy (i.e., ability to reduced drug liking following opioid administration) (Aim 3). The oxycodone vaccine (Oxy(Gly)4-sKLH) will be tested in participants with OUD (target # completers = 45 across two study sites). This study will provide a great deal of information about the safety and potential effectiveness of the Oxy(Gly)4-sKLH vaccine in reducing the abuse of opioids. The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Начало: 08.10.2020 Край: 30.03.2027 Възраст: 18–59 г.

United States New York State Psychiatric Institute NCT04458545

Набира участници

Pancreatic Cancer Early Detection Consortium

Pancreas Cancer Pancreas Cyst Pancreatic Ductal Adenocarcinoma Genetic Predisposition

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

Начало: 18.09.2020 Край: 31.12.2030 Възраст: 18–90 г.

Australia, Canada, Hungary +8 Arbor Research Collaborative for Health NCT04970056

Набира участници

Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)

Idiopathic Normal Pressure Hydrocephalus

The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research

Начало: 15.09.2020 Край: 30.12.2026 Възраст: 60–90 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT04998175

Набира участници Фаза 2

Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies

Melanoma NSCLC Hepatocellular Carcinoma Urothelial Cancer +4

Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional/incisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+/- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional/incisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.

Начало: 14.09.2020 Край: 02.10.2027 Възраст: от 18 г.

United States Dan Zandberg NCT04114136

Набира участници

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Bladder Cancer

Background: Bladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors. Objective: To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens. Eligibility: People ages 18 and older who need to have their bladder removed at the NIH. Design: Participants will be screened with: Medical and prior surgical history Review of existing MRI, x-ray, or CT scans Review of existing specimens and reports Pregnancy test for women of childbearing age CT or MRI: Participants will lie in a machine. The machine will take pictures of their body. Participants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review. Participants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled. ...

Начало: 09.09.2020 Край: 30.09.2027 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT04235764

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