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Recruiting NCT02688517

Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

Conditions: Malignant Neoplasm

Sponsor: Rutgers, The State University of New Jersey

trial.available_in: БГ
Overview
This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.
Description
PRIMARY OBJECTIVES: I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies. II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed. III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data. IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models. OUTLINE: Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells. After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.
Who can participate
Inclusion Criteria: * Karnofsky/Lansky performance score \>= 30 * A signed written informed consent * Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment * Paraffin blocks of the patient's tumor tissue are available and accessible for analysis Exclusion Criteria: * Karnofsky/Lansky performance score \< 30 * Life expectancy \< 3 months
Interventions
Cytology Specimen Collection Procedure
OTHER
Laboratory Biomarker Analysis
OTHER
Locations 11
United States (11)
Ocean Medical Center
Brick , New Jersey
COMPLETED
Bayshore Community Hospital
Holmdel , New Jersey
COMPLETED
RWJBarnabas Health - Jersey City Medical Center, Jersey City
Jersey City , New Jersey
University of Wisconsin Hospital and Clinics
Madison , Wisconsin
WITHDRAWN
Southern Ocean County Medical Center
Manahawkin , New Jersey
COMPLETED
Morristown Medical Center
Morristown , New Jersey
COMPLETED
Jersey Shore Medical Center
Neptune City , New Jersey
COMPLETED
Rutgers Cancer Institute of New Jersey
New Brunswick , New Jersey
Clinical Trials Office
Riverview Medical Center/Booker Cancer Center
Red Bank , New Jersey
COMPLETED
Riverview Medical Center
Red Bank , New Jersey
ACTIVE_NOT_RECRUITING
Overlook Hospital
Summit , New Jersey
COMPLETED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
1 Year
Healthy volunteers
No
Start date
01.02.2013
Completion date
01.05.2030
Registry ID
NCT02688517
Source
clinicaltrials.gov
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