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Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment (MSN)

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ClinicalTrials.gov Identifier: NCT02105168
Recruitment Status : Unknown
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : April 7, 2014
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Non Small Cell Lung Cancer Small Cell Lung Cancer Procedure: Blood sample Procedure: Tumorous biopsy Procedure: Healthy material sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma
Study Start Date : July 2009
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: Experimental arm
Blood sample Tumorous biopsy Healthy material sample
Procedure: Blood sample
Optional

Procedure: Tumorous biopsy
Optional

Procedure: Healthy material sample
Optional




Primary Outcome Measures :
  1. Mutation rate on tumorous material [ Time Frame: Assessed at the time of inclusion ]
    Assessed at the time of inclusion using tumorous material used for diagnosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105168


Contacts
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Contact: Benjamin Besse, MD 0142114317 ext +33 benjamin.besse@gustaveroussy.fr
Contact: Caroline Robert, MD 0142114211 ext +33 caroline.robert@gustaveroussy.fr

Locations
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France
Gustave Roussy Cancer Campus Grand Paris Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Benjamin Besse, MD    0142114317 ext +33    benjamin.besse@gustaveroussy.fr   
Principal Investigator: Caroline Robert, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
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Study Chair: Benjamin Besse, MD Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02105168     History of Changes
Other Study ID Numbers: 2008-A00373-52
2007/1363 ( Other Identifier: CSET number )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Melanoma
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas