Non-small Cell Lung CancerSITRRNCT02075957
Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by University Hospital, Angers at 1 site in France.
Trial summary
Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jun 2016
- 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: Patients with non small cell lung cancer
Who may be able to join
- Major subject
- Subject who received resection with primary non-small cell lung cancer at the University Hospital of Angers and whose tumor samples will be stored in collection of biological resources of University Hospital of Angers
- A written inform consent.
Who cannot join
- Under 18 year old;
- Pregnant or nursing women;
- Deprived of liberty;
- Age under curatorship or guardianship;
- Unable to consent person;
- About not carrying a non-small cell lung cancer.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Angers
Angers, Maine et Loire, 49933
José HUREAUX, Doctor, 2 41 35 36 78 ext. +33, johureaux@chu-angers.fr
Amandine AULNETTE, CRA, 2 41 35 80 15 ext. +33, amandine.aulnette@chu-angers.fr
About this study
Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC).
Read the detailed description
- A first blood sample will be taken during the week before the operation. A second blood sample will be taken 4 to 8 weeks after the operation. And in case of relapse, a third sample will be taken. These samples are going to be stored in the collection of biological resources of Angers.
- Concerning the biopsy of the resected NSLCL, it will be sent to the collection of biological resources of Angers for conservation directly next to the surgery.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, adjuvant chemo-therapy, DNA chip
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: 6 to 8 weeks after surgery
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 1 year
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 2 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 3 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 4 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 5 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 6 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 7 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 8 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 9 years
Determination of news microarrays profiles of NSCLC relapse risks
The news microarrays profiles of NSCLC relapse risks will :
- assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)
- assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient
- assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- José HUREAUX, Doctor, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075957
- Sponsor's protocol ID
- 2012-A00827-36
- Acronym
- SITRR
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02075957
- Acronym / sponsor ID
- SITRR / 2012-A00827-36
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, adjuvant chemo-therapy, DNA chip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Mar 2014 (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.
Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC).
Detailed description
- A first blood sample will be taken during the week before the operation. A second blood sample will be taken 4 to 8 weeks after the operation. And in case of relapse, a third sample will be taken. These samples are going to be stored in the collection of biological resources of Angers.
- Concerning the biopsy of the resected NSLCL, it will be sent to the collection of biological resources of Angers for conservation directly next to the surgery.
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
- Patients with non small cell lung cancer
Key inclusion criteria (3 listed)
- Major subject
- Subject who received resection with primary non-small cell lung cancer at the University Hospital of Angers and whose tumor samples will be stored in collection of biological resources of University Hospital of Angers
- A written inform consent.
Key exclusion criteria (6 listed)
- Under 18 year old;
- Pregnant or nursing women;
- Deprived of liberty;
- Age under curatorship or guardianship;
- Unable to consent person;
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
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: 6 to 8 weeks after surgery
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 1 year
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 2 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 3 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 4 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 5 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 6 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 7 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 8 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 9 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Determination of news microarrays profiles of NSCLC relapse risks
Time frame: At 10 years
The news microarrays profiles of NSCLC relapse risks will : * assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk) * assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient * assessing the prediction of sites most likely metastatic relapse to guide survey strategy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
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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.
José HUREAUX, Doctor principal investigator
University Hospital, Angers
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 Non-small Cell Lung Cancer, run by University Hospital, Angers 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José HUREAUX, Doctor (241353678 ext. +33, johureaux@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of news microarrays profiles of NSCLC relapse risks (time frame: 6 to 8 weeks after surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2014.