Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

Обзор

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence

Подробное описание

The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.

PRIMARY OBJECTIVE:

To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.

SECONDARY OBJECTIVE:

Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.

EXPLORATORY OBJECTIVE:

Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers

Вмешательства

• Другое RIsk-Reducing Salpingectomy (RRS)
  complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
• Другое Risk-Reducing Oophorectomy-RRO
  complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
• Другое Risk-Reducing Salpingo-Oophorectomy-RRSO
  complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Первичные конечные точки

• To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers. [Срок оценки: through study completion, an average of 15 years]

Критерии участия

Критерии включения

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
• Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2.

• The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.
• No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
• Presence of at least one fallopian tube.
• Participants may have a personal history of non-ovarian malignancy.
• Informed consent must be obtained and documented.

Критерии исключения

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Postmenopausal status (natural menopause or due to (cancer) treatment)

• A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.
• Wish for second stage RRO within two years after RRS (if clear at enrollment)
• Legally incapable
• Prior bilateral salpingectomy
• A personal history of ovarian, fallopian tube, or peritoneal cancer
• Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 9 центров

• Dana Farber Cancer Institute — Boston
• Mayo Clinic — Rochester
• WU St Louis — St Louis
• Mount Sinai Health System — New York
• Memorial Sloan Kettering Cancer Center — New York
• University of Pennsylvania — Philadelphia
• Lyndon Baines Johnson General — Houston
• M D Anderson Cancer Center — Houston
• … и ещё 1 центр

Идентификаторы

NCT: NCT05287451 · 2021-1089 · NCI-2022-01291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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