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

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

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.

Study Overview

• Status: Unknown
• Conditions: Melanoma; Circulating Tumor Cell
• Intervention / Treatment: Procedure: Biological sample

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Saint-Louis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: Biological sample; Biological sample performed : before treatment; 1 months after the beginning of treatment; every tumoral assessment
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).	Procedure: Biological sample; Biological sample performed : before treatment; 1 months after the beginning of treatment; every tumoral assessment

What is the study measuring?

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	Time Frame
Survival	5 years
Survival	3 years
Survival	1 year
Disease free Survival	1 year
Disease free Survival	3 years
Disease free Survival	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; ScreenCell; Celenys; Imstar

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2015
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: NI15009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No