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Biological Study of Feasibility Concerning the Research for Mutation of the Gene of EGFR and for K-Ras in Circulating Tumoral Cells(CTCs) of the Patients Carriers of Metastatic Non Small Cells Bronchial Carcinomas


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer Metastatic

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Trial Information

Biological Study of Feasibility Concerning the Research for Mutation of the Gene of EGFR and for K-Ras in Circulating Tumoral Cells(CTCs) of the Patients Carriers of Metastatic Non Small Cells Bronchial Carcinomas


Inclusion Criteria:



1. men and women

2. age over 18 y.o.

3. signed informed consent form.

4. Patients barriers of Non-small Cell Lung Cancer Metastatic

5. chemotherapy non yet begun

6. patients barrier of CTC

7. Research for mutation of EGFR and Kras made on the primitive tumor

8. Man and woman old enough to procreate under effective contraceptives

Exclusion Criteria:

1. small cells bronchial cancer

2. Non metastatic bronchial cancer

3. Absence of detectable CTC at the patient

4. Private individuals of freedom or under tutelage (including legal guardianship)

5. Incapacity to sign the inform consent form or psychiatric, behavioural disorders or
geographical situation precluding the follow-up of the protocol

6. Pregnancy, lactating or refusal of the contraception for women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

search for the mutation of EGFR and Kras in the CTC of the patient

Outcome Time Frame:

september 2012 (anticpated) up to 2 years

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0416-1cobr10

NCT ID:

NCT01380795

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • non-small cell lung cancer carcinoma
  • circulating tumor cells
  • EGFR
  • K-ras
  • Carcinoma
  • Carcinoma, Bronchogenic
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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