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NCT02105168 Clinical Trial

Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment

Melanoma Clinical Trial

— MSN  

Official title:
Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02105168
Other study ID # 2008-A00373-52
Secondary ID 2007/1363
Status Recruiting
Phase N/A
First received March 31, 2014
Last updated June 9, 2016
Start date July 2009
Est. completion date July 2019

Study information
Verified date June 2016
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Benjamin Besse, MD
Phone 0142114317
Email benjamin.besse@gustaveroussy.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.

Recruitment information / eligibility
Status Recruiting
Enrollment 2200
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Cytological or histological diagnosis of SCLC, NSCLC or melanoma

2. Patients age >/= 18 years old

3. Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated

4. If a biopsy is proposed, lesion lust be easily accessible

5. Signed informed consent

Exclusion Criteria:

1. Patients unable to follow the protocol

2. Consent refusal

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample
Optional
• Tumorous biopsy
Optional
• Healthy material sample
Optional

Locations
Country Name City State
France Gustave Roussy Cancer Campus Grand Paris Villejuif Val de Marne

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mutation rate on tumorous material Assessed at the time of inclusion using tumorous material used for diagnosis Assessed at the time of inclusion No
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