Carcinoma, Non-Small-Cell LungPharmacogenosNCT00222404
Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"
An observational study of Carcinoma, Non-Small-Cell Lung, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 556 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2005to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Previous or Concomitant carcinoma over 5 last years
- Concomitant radiotherapy
- Cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.
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.
Read the detailed description
Lung carcinoma will be the fifth death cause in the world in 2020. In Europe it causes more deaths than carcinoma of breast, colon and prostate combined so it is a public healthcare priority. Applying high throughput molecular analysis technologies to pharmacogenomics could improve lung carcinoma care strategies. The study hypothesis is that the determination of the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow treatment targeting , improving treatment efficacy and tolerance.
In order to carry out this study, the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM (French national research institute) units and new biotechnology companies.
The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas.
Biological samples will be collected before and during patient care to correlate clinical evolution (response and tolerance) with:
- circulating cell polymorphism profile
- proteomic profile
- genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism, apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.
The main judgment criteria will be response to chemotherapy correlated with patient's biological profile.
Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy.
The second purpose of this study is to validate less invasive methods of sampling using blood, expectoration, urine, fixed biopsies and lungs tapping, as a substitute to the current reference (frozen tumor), which is out of reach in clinical examination.
This will contribute to setting of a multicentric resources bank, to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies.
Two previous studies (1800 and 500 patients respectively) have already been carried out, data and samples are available.
For this study, 600 patients will be included over 3 years.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Pharmacogenomic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Chritian Brambilla, Pr., Study director, INSERM U578
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222404
- Sponsor's protocol ID
- DCIC 04 40
- Acronym
- Pharmacogenos
- Status last verified
- Nov 2010
- First submitted
- 14 Sep 2005
- Last updated
- 5 Nov 2010
- Results posted
- No
Publications
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.
PubMed 12118244Dumontet 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.
PubMed 10071301Dumontet 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.
PubMed 11380469Galmarini 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.
PubMed 12142171Howard 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.
PubMed 12973732Tissot 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.
PubMed 26493785Toffart 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.
PubMed 25527907Toffart 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.
PubMed 25323247
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.
- ClinicalTrials.gov ID
- NCT00222404
- Acronym / sponsor ID
- Pharmacogenos / DCIC 04 40
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Pharmacogenomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2005
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung carcinoma will be the fifth death cause in the world in 2020. In Europe it causes more deaths than carcinoma of breast, colon and prostate combined so it is a public healthcare priority. Applying high throughput molecular analysis technologies to pharmacogenomics could improve lung carcinoma care strategies. The study hypothesis is that the determination of the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow treatment targeting , improving treatment efficacy and tolerance.
In order to carry out this study, the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM (French national research institute) units and new biotechnology companies.
The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas.
Biological samples will be collected before and during patient care to correlate clinical evolution (response and tolerance) with:
- circulating cell polymorphism profile
- proteomic profile
- genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism, apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.
The main judgment criteria will be response to chemotherapy correlated with patient's biological profile.
Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy.
The second purpose of this study is to validate less invasive methods of sampling using blood, expectoration, urine, fixed biopsies and lungs tapping, as a substitute to the current reference (frozen tumor), which is out of reach in clinical examination.
This will contribute to setting of a multicentric resources bank, to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies.
Two previous studies (1800 and 500 patients respectively) have already been carried out, data and samples are available.
For this study, 600 patients will be included over 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Previous or Concomitant carcinoma over 5 last years
- Concomitant radiotherapy
- Cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
- Background: PubMed 12118244Beer 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.
- Background: PubMed 10071301Dumontet 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.
- Background: PubMed 11380469Dumontet 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.
- Background: PubMed 12142171Galmarini 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.
- Background: PubMed 12973732Howard 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.
- Derived from this study: PubMed 26493785Tissot 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.
- Derived from this study: PubMed 25527907Toffart 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.
- Derived from this study: PubMed 25323247Toffart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chritian Brambilla, Pr. study director
INSERM U578
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222404, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.