Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Percentage of cases with identified circulating tumor cells.
研究概览
简要总结
This is a prospective interventional single-site research with a collection of biological samples.
The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.
Five groups will be constitued: at first the Group 0: Healthy volunteers included for the spike-in test; and then the four groups, Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer; Group 4: Healthy volunteers included as control).
In each group, the percentage of cases with identified circulating tumor cells will be estimated.
详细描述
This is a prospective interventional single-site research with a collection of biological samples ("Recherche Impliquant la Personne Humaine de type 2" according to French legislation).
First, a cohort of 20 healthy volunteers (Group 0: Healthy volunteers included for the spike-in test) will be constituted for the spike-in-test.
Then, recruitment of the three groups of 14 patients each (Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer) and the control group of 14 healthy volunteers (Group 4: Healthy volunteers included as control) will be done in parallel.
In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success will be defined as follows: the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.
Circulating tumor cells (CTC) will be identified as followed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •Registered with a social security system
- •Signed, IRB-approved written informed consent
- •Belonging to one of the following group:
- •Group 1 - HER-2 positive breast cancer, defined as followed: histologically-proven, HER-2 positive breast cancer, with metastasis (stage IV) requiring first-line treatment
- •Group 2 - Advanced ovarian cancer, defined as followed: histologically-proven, stage III or IV ovarian cancer requiring first-line chemotherapy
- •Group 3 - Metastatic prostate cancer, defined as followed: histologically-proven, stage IV, castrate-resistant prostate cancer requiring chemotherapy with docetaxel or treatment with 2nd generation hormonal therapy (e.g. enzalutamide or abiraterone)
- •Groups 0 and 4 - Healthy volunteers defined as followed: No prior personal history of malignant disease
排除标准
- •Pregnant or breastfeeding woman
- •Patient under guardianship or curatorship
结局指标
主要结局
Percentage of cases with identified circulating tumor cells.
时间窗: within 24 hours after inclusion (blood sample collection)
To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients. In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach. Failure: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique. To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as: * HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1) * CA 125-positive using immuno-histochemistry (IHC) (Group 2) * PSA-positive using IHC (Group 3)
次要结局
- Description of the isolated circulating cell(within 24 hours after inclusion (blood sample collection))
- Percentage of cases with identified circulating tumor cells after frozen storage(within 24 hours after inclusion (blood sample collection))