NCT00222404

Brief Summary

The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 5, 2010

Status Verified

November 1, 2010

First QC Date

September 14, 2005

Last Update Submit

November 4, 2010

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell LungPharmacogenomic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma * Patient treated by chemotherapy with platinum salt * Every stage TNM classification * No previous chemotherapy * One measurable lesion out of nervous central system at least

You may qualify if:

  • Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma
  • Patient treated by chemotherapy with platinum salt
  • Every stage TNM classification
  • No previous chemotherapy
  • One measurable lesion out of nervous central system at least
  • Performance status from 0 to 2 on ECOG scale
  • Life expectancy \> 12 weeks

You may not qualify if:

  • Previous or Concomitant carcinoma over 5 last years
  • Concomitant radiotherapy
  • Cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38000, France

Location

Related Publications (8)

  • Beer DG, Kardia SL, Huang CC, Giordano TJ, Levin AM, Misek DE, Lin L, Chen G, Gharib TG, Thomas DG, Lizyness ML, Kuick R, Hayasaka S, Taylor JM, Iannettoni MD, Orringer MB, Hanash S. Gene-expression profiles predict survival of patients with lung adenocarcinoma. Nat Med. 2002 Aug;8(8):816-24. doi: 10.1038/nm733. Epub 2002 Jul 15.

    PMID: 12118244BACKGROUND

  • Dumontet C, Sikic BI. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol. 1999 Mar;17(3):1061-70. doi: 10.1200/JCO.1999.17.3.1061.

    PMID: 10071301BACKGROUND

  • Dumontet C, Morschhauser F, Solal-Celigny P, Bouafia F, Bourgeois E, Thieblemont C, Leleu X, Hequet O, Salles G, Coiffier B. Gemcitabine as a single agent in the treatment of relapsed or refractory low-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Jun;113(3):772-8. doi: 10.1046/j.1365-2141.2001.02795.x.

    PMID: 11380469BACKGROUND

  • Galmarini CM, Mackey JR, Dumontet C. Nucleoside analogues and nucleobases in cancer treatment. Lancet Oncol. 2002 Jul;3(7):415-24. doi: 10.1016/s1470-2045(02)00788-x.

    PMID: 12142171BACKGROUND

  • Howard BA, Wang MZ, Campa MJ, Corro C, Fitzgerald MC, Patz EF Jr. Identification and validation of a potential lung cancer serum biomarker detected by matrix-assisted laser desorption/ionization-time of flight spectra analysis. Proteomics. 2003 Sep;3(9):1720-4. doi: 10.1002/pmic.200300514.

    PMID: 12973732BACKGROUND

  • Tissot C, Toffart AC, Villar S, Souquet PJ, Merle P, Moro-Sibilot D, Perol M, Zavadil J, Brambilla C, Olivier M, Couraud S. Circulating free DNA concentration is an independent prognostic biomarker in lung cancer. Eur Respir J. 2015 Dec;46(6):1773-80. doi: 10.1183/13993003.00676-2015. Epub 2015 Oct 22.

    PMID: 26493785DERIVED

  • Toffart AC, Moro-Sibilot D, Couraud S, Merle P, Perol M, Girard N, Souquet PJ, Mastroianni B, Ferretti GR, Romand P, Chatellain P, Vesin A, Brambilla E, Brambilla C, Timsit JF. Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study. BMC Cancer. 2014 Dec 20;14:989. doi: 10.1186/1471-2407-14-989.

    PMID: 25527907DERIVED

  • Toffart AC, Pizarro CA, Schwebel C, Sakhri L, Minet C, Duruisseaux M, Azoulay E, Moro-Sibilot D, Timsit JF. Selection criteria for intensive care unit referral of lung cancer patients: a pilot study. Eur Respir J. 2015 Feb;45(2):491-500. doi: 10.1183/09031936.00118114. Epub 2014 Oct 16.

    PMID: 25323247DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chritian Brambilla, Pr.

    INSERM U578

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Study Completion

August 1, 2010

Last Updated

November 5, 2010

Record last verified: 2010-11

Locations

FR(1)