Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology

Study Overview
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Brief Summary
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Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates. Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because circulating blood collection is simple and non-invasive, CTCs can be used as a marker to track disease progression and survival in real time. CTCs could also guide therapeutic choice.

Official Title
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Expansion ex Vivo Des Cellules Tumorales Circulantes Comme modèle de Pharmacologie prédictive Des Cancers. EXPEVIVO-CTC

Conditions
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Melanoma, Circulating Tumor Cell

Intervention / Treatment
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* Procedure: Biological sample


Participation Criteria
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Eligibility Criteria
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COHORT 1 Inclusion Criteria: Histologically confirmed cutaneous or mucosal melanoma (per American joint committee on cancer (AJCC) staging system) that is unresectable or metastatic No prior systemic anticancer therapy for unresectable/metastatic melanoma or clinical/radiological disease progression (RECIST1.1) if previously treated and before new treatment No prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as cutaneous carcinoma or cervix) followed in Saint Louis Hospital Tumor tissue available in Saint Louis Hospital Subjects must have signed and approved written informed consent form No pregnancy Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus Exclusion Criteria: None COHORT 2 : Inclusion Criteria : Histologically confirmed cutaneous or mucosal melanoma Candidates for sentinel lymph node analysis and surgical recovery (this examination is in practice reserved for melanomas >1mm thick or ulcerated) No prior adjuvant anticancer therapy followed in Saint Louis Hospital Tumor tissue available in Saint Louis Hospital Subjects must have signed and approved written informed consent form No pregnancy Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus Exclusion Criteria: None

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 : metastatic cohort<br>Cohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value). | Procedure: Biological sample<br>* Biological sample performed : before treatment 1 months after the beginning of treatment every tumoral assessment<br>|
| Cohort 2 : adjuvant cohort<br>Cohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis. This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis). | Procedure: Biological sample<br>* Biological sample performed : before treatment 1 months after the beginning of treatment every tumoral assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutical response | Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 year | 
| Survival |  | 3 years | 
| Survival |  | 5 years | 
| Disease free Survival |  | 1 year | 
| Disease free Survival |  | 3 years | 
| Disease free Survival |  | 5 years |