Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology (EXPEVIVO-CTC)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Melanoma; Circulating Tumor Cell

Treatments: Procedure: Biological sample

Study type: Observational

Funder types: Other

Identifiers

NCT03797053

NI15009

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

450 participants in 2 patient groups

Cohort 1 : metastatic cohort

Description:

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).

Treatment:

Procedure: Biological sample

Cohort 2 : adjuvant cohort

Description:

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).

Treatment:

Procedure: Biological sample