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

Melanoma Clinical Trial

— EXPEVIVO-CTC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797053
• Other study ID #: NI15009
• Status: Recruiting
• Start date: April 6, 2015
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Celeste Lebbe, MD PhD
• Phone: 142499590
• Email: celeste.lebbe[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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:

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Melanoma
• Neoplastic Cells, Circulating

Intervention

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

Locations

Country	Name	City	State
France	Saint-Louis Hospital	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Celenys, Imstar, Institut National de la Santé Et de la Recherche Médicale, France, ScreenCell

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival		1 year
Secondary	Survival		3 years
Secondary	Survival		5 years
Secondary	Disease free Survival		1 year
Secondary	Disease free Survival		3 years
Secondary	Disease free Survival		5 years