Using a Blood Test to Monitor Metastatic Breast Cancer Treatment
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Metastatic Breast Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
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Официальное название
Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment
Обзор
The goal of this observational study is to assess the effectiveness of the mDETECT breast cancer blood test at monitoring treatment response in women with metastatic breast cancer undergoing treatment.
Подробное описание
Breast cancer is the most common cancer in Canadian women. While survival rates for women with metastatic breast cancer have almost doubled in the last 20 years, the 5-year survival rate is about 25%. Currently, determining whether a breast cancer therapy is working is very difficult. Women undergo CT-scans every three months to assess the effectiveness of their therapy. If the chosen treatment is not effective, a patient would have been delayed in receiving a more effective treatment and will be exposed to the serious side effects of their ineffective treatment during this time.
The investigators have developed a blood test, called mDETECT, which is a DNA methylation-based liquid biopsy that targets multiple tumour specific hypermethylated regions on DNA. DNA shed from tumours travels through the blood stream and which can be collected through a blood draw and analyzed for breast cancer specific methylation patterns. The mDETECT breast cancer assay is sensitive and specific and has been proven to work well in detecting breast cancer in women with metastatic disease. This assay has been designed to work with all subtypes of breast cancer. Moreover, this blood test measures changes in the size of the tumour; therefore, it will work with any treatment.
The goal of this observational study is to assess the effectiveness of the mDETECT breast cancer blood test in women undergoing treatment for metastatic breast cancer to determine if a response to therapy can be seen earlier than the current 3 month time point for CT-scans. In this study, women undergoing treatment for metastatic breast cancer will be recruited. Participants will have blood drawn at baseline and multiple timepoints throughout treatment. The participants will also be monitored using the current standard of care, imaging every 3 months with CT-scans. The aim of this study will be to determine if the mDETECT blood test can predict within the first few weeks of treatment the results of the 3 month CT-scan.
Первичные конечные точки
- Change in ctDNA level from baseline to 6 months of treatment [Срок оценки: Baseline - 6 months]
- Changes in radiographic tumour assessments for monitoring response to treatment [Срок оценки: 3 months and 6 months]
- Change in measurable lytic lesions in participants with bone only metastasis assessed by CT scans as measured per RECIST v.1.1 [Срок оценки: 3 months and 6 months]
Вторичные конечные точки (1)
- Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment [Срок оценки: Baseline - 6 months]
Критерии участия
Критерии включения
-Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent \[to be herein described as 'metastatic'\]
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 2 центра
- Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario — Kingston
- Sunnybrook Health Sciences Centre — Toronto
Идентификаторы
NCT: NCT05804578 · 6037248 · 486377