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Активно (без набиране) Фаза 2 NCT03480776

ASA in Prevention of Ovarian Cancer (STICs and STONEs)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Ovarian Cancer Prevention

Спонсор: Canadian Cancer Trials Group

Налично на: БГ
Обобщение
While ASA is not a cancer medication, research suggests that taking ASA reduces the probability of getting many types of cancer because of its anti-inflammatory action. Inflammation in the ovaries during ovulation is thought to contribute to the development of ovarian cancer, and, because ASA is an anti-inflammatory medication, it may help to prevent it.
Описание
The standard or usual treatment for women with a high risk gene mutation, BRCA1 or BRCA2, is to have risk-reducing surgery to remove the fallopian tubes and ovaries (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) after they have decided not to have more children naturally. Acetylsalicylic Acid (ASA) is a safe, well tolerated drug taken by mouth. ASA has been available for over 100 years and has been used mainly to relieve fever and pain, but also as an anti-inflammatory medication in order to reduce inflammation (swelling).
Кой може да участва
Inclusion Criteria: * Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines * Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families * ECOG performance status 0 or 1 * Age ≥ 18 years old * Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French. * Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate * Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization * Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication Exclusion Criteria: * Subjects with history of other malignancies, except: * adequately treated non-melanoma skin cancer; * curatively treated in-situ cancer of the cervix; * previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time. * other solid tumours curatively treated with no evidence of disease for \> 5 years. * Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time. * Subjects with active bleeding or bleeding diathesis. * Subjects with active peptic ulcer. * Subjects with renal, hepatic or congestive heart failure. * Subjects with concurrent use of anti-coagulants and/or anti-platelet agents. * Subjects with prior bilateral salpingectomy. * Subjects with history of chronic daily use of ASA or NSAIDs. * Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs. * Ongoing or planned pregnancy. * Subjects who are breastfeeding.
Места на провеждане 2
Австралия (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Канада (1)
Tom Baker Cancer Centre
Calgary , Alberta
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
24.07.2018
Крайна дата
15.09.2026
Регистрационен номер
NCT03480776
Източник
anzctr
Запитване за медицински туризъм

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