Study Looking at Biomarkers in Ovarian Cancer

Официальное название

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Обзор

This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.

Вмешательства

• Процедура Tumour tissue collection
  Tumour tissue will be taken from samples already removed from surgery or biopsy or by new tumour biopsies: * At the time of diagnosis or progression * Any surgical procedures for management of tumour related medical conditions * At each subsequent relapse or disease progression
• Процедура Blood sample collection
  Blood samples will be taken: * At the time of first diagnosis * About 1 week after starting any treatment * At each radiological response assessment * At each subsequent relapse or disease progression
• Процедура Ascites Collection
  Ascites will be collected if paracentesis is required during any of the following time points: * At the time of diagnosis or progression * Any surgical procedures for management of tumour related medical conditions * At each subsequent relapse or disease progression
• Процедура Fluid Collection
  Additional fluid will be collected at any time a procedure for clinical management that involves the drainage of fluid (i.e. thoracentesis, or drainage of cystic lesion) is required.

Первичные конечные точки

• Genomic and immune signatures in terms of progression free survival [Срок оценки: 10 years]
• Genomic and immune signatures in terms of overall survival [Срок оценки: 10 years]
• Genomic and immune signatures in terms of response to treatments [Срок оценки: 10 years]
• Genomic and immune signatures in terms of resistance to treatments [Срок оценки: 10 years]

Критерии участия

Критерии включения

• Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer.
• Must be 18 years of age or older.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Have a life expectancy greater than or equal to 6 months.
• Able to provide adequate informed consent.
• Willing to undergo blood or fluid collection and tumour biopsy
• Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study.
• Archival tissue must be available for patients that are enrolled at the time of progression.

Критерии исключения

• Must not have early stage (I and II) high grade serous, tubal or primary peritoneal cancer.
• Must not have other tumour histology other than high grade serous.
• Must not have contraindication to tumour biopsy and/or blood sampling.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Канада · 7 центров

• Royal Victoria Regional Health Centre — Barrie
• Juravinski Cancer Centre — Hamilton
• Kingston Health Sciences Centre — Kingston
• London Health Sciences Centre — London
• The Ottawa Hospital Cancer Centre — Ottawa
• Sunnybrook Health Sciences Centre — Toronto
• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT03419689 · BioDIVA (17-5467)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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