Feasibility of a New Technology for Isolating Circulating Tumour Cells

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization (FISH) to be regarded as true CTC Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry (IHC) to be regarded as true CTC Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls, if putative circulating cells are observed, these healthy volunteers will be tested against the three markers (HER2, CA-125 and PSA). Failure will be defined as follows: 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. The different characteristics of these cells will be described: size, cytological characteristics, number, etc. Secondary collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC. 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.

Official Title
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Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers

Conditions
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HER2-positive Metastatic Breast Cancer, Ovarian Cancer, Hormone-resistant Prostate Cancer, Circulating Tumor Cell

Intervention / Treatment
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* Procedure: Blood sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant or breastfeeding woman Patient under guardianship or curatorship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood sample collection<br>For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes) | Procedure: Blood sample collection<br>* A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of cases with identified circulating tumor cells. | 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) | within 24 hours after inclusion (blood sample collection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the isolated circulating cell | Describe the different characteristics of these cells: size, cytological characteristics, number ... These informations will allow to characterize the isolated circulating cells. | within 24 hours after inclusion (blood sample collection) | 
| Percentage of cases with identified circulating tumor cells after frozen storage | To assess the ability of the new technology to isolating CTC As secondary collected, collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to our capacity for isolating the CTC. In each group, the percentage of cases with identified circulating tumor cells will be estimated. 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) | within 24 hours after inclusion (blood sample collection) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating Tumour Cells, Selected cancer patients, New technology