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

NCT03797053 | Unknown DMC

• 1 other identifier: NI15009
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Survival

  1 year

• Survival

  3 years

• Survival

  5 years

• Disease free Survival

  1 year

• Disease free Survival

  3 years

Study Arms (2)

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

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

Interventions

Biological sample PROCEDURE

Biological sample performed : * before treatment * 1 months after the beginning of treatment * every tumoral assessment

Cohort 1 : metastatic cohort; Cohort 2 : adjuvant cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• None
• COHORT 2 :
• 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
• None

Sponsors & Collaborators

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

Study Sites (1)

Saint-Louis Hospital

Paris, 75010, France

RECRUITING

Biospecimen

Retention: NONE RETAINED

Blood Sample

MeSH Terms

Conditions

Melanoma; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Celeste Lebbe, MD PhD

CONTACT

142499590; celeste.lebbe@aphp.fr

Matthieu RESCHE-RIGON, MD PhD

CONTACT

142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: January 8, 2019
• Study Start: April 6, 2015
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 8, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)