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| Name | Class |
|---|---|
| ScreenCell | INDUSTRY |
| Celenys | UNKNOWN |
| Imstar | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 : metastatic cohort | 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). |
| |
| Cohort 2 : adjuvant cohort | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological sample | Procedure | Biological sample performed :
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 1 year | |
| Survival | 3 years | |
| Survival |
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COHORT 1
Inclusion Criteria:
Exclusion Criteria:
COHORT 2 :
Inclusion Criteria :
Exclusion Criteria:
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Cohort1: Cohort of patients with stage III unresectable or IV metastatic melanoma patients Cohort 2: Cohort of patients with melanoma candidates for sentinel lymph node analysis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celeste Lebbe, MD PhD | Contact | 142499590 | +33 | celeste.lebbe@aphp.fr |
| Matthieu RESCHE-RIGON, MD PhD | Contact | 142499742 | +33 | matthieu.resche-rigon@univ-paris-diderot.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Louis Hospital | Recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| OTHER_GOV |
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Blood Sample
| 5 years |
| Disease free Survival | 1 year |
| Disease free Survival | 3 years |
| Disease free Survival | 5 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |