Status:
UNKNOWN
Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
ScreenCell
Celenys
Conditions:
Melanoma
Circulating Tumor Cell
Eligibility:
All Genders
18+ years
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 metastat...
Eligibility Criteria
Inclusion
- COHORT 1
- 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
- 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
Key Trial Info
Start Date :
April 6 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03797053
Start Date
April 6 2015
End Date
June 30 2019
Last Update
January 8 2019
Active Locations (1)
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1
Saint-Louis Hospital
Paris, France, 75010