Lung CancerBio-lungNCT03387865
A Clinico-biological Database of Lung Cancers
An observational study of Lung Cancer, run by University Hospital, Lille at 1 site in France.
Trial summary
This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- tissue biopsies, blood sampling and DNA banking
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2019to Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study includes patients taken in charge at UH Lille, department of pneumology and thoracic oncology (may be also treated at thoracic surgery department, in same hospital). The subjects have a lung cancer diagnosis (all stages are eligible) or a suspicion of lung cancer ; they are included before any treatment initiation.
Who may be able to join
- Documented new diagnosis of lung cancer by histology or cytology, or lung tumor leading to lung cancer suspicion without diagnosis for which an antineoplastic treatment is indicated
- Indication of a treatment by surgery, chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy as first line of lung cancer treatment
- ability of the subject to follow study procedures
- Age > 18 years
- Subject must have at least one measurable and/or assessable lesion in regard with RECIST 1.1 criteria
- Subject is registered with a social security scheme
- Subject is taken in charge at Pneumology department of Lille UH
- Subject has signed an informed consent form
Who cannot join
- Patient with a history of treatment by antineoplastic chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy, or presenting a contra indication to antineoplastic treatment administration
- Subject is not willing to sign the informed consent form
- Subject is not registered with a social security scheme
- Subject is not francophone
- Subject is deprived of his/her liberty or under trusteeship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Calmette, CHU
Lille
Alexis Cortot, MD,PhD
About this study
This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.
Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.
- Conditions
- Lung Cancer
- Being tested
- tissue biopsies, blood sampling, DNA banking
- Keywords
- banking, biological sampling, tumor tissue, tumor response
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue biopsiesProcedure or surgery
additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.
blood samplingProcedure or surgery
additional blood samples will be collected during a SOC sampling procedure (2 EDTA 7.5 ml tubes, 2 SST 7.5 ml tubes and 2 citrate 5 ml tubes)
DNA bankingGenetic
constitutional and somatic genetic alterations will be analysed for subjects who consent, from either tumor or healthy tissue, or whole blood buffy coat after centrifugation
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate assessed by CT scan
Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (partial response defined as a decrease of at least 30% in size of target lesions, complete response defined as a disappearance of all lesions)
Measured: 8 weeks
Secondary outcomes (4)
Disease progression rate assessed by CT scan
Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (disease progression defined as an increasement of at least 20 % in size of target lesions, and/or appearance of new lesions)
Measured: 8 weeks
Progression-free survival
Measured: 8 weeks
Overall survival
number of subjects alive
Measured: 1 year
treatment toxicity
length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start13 Mar 2019
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille, University of Lille Nord de France
- Responsible party
- Sponsor
- Investigators
- Alexis CORTOT, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387865
- Sponsor's protocol ID
- 2015_43
- Other IDs
- 2016-A01383-48
- Acronym
- Bio-lung
- Status last verified
- May 2026
- First submitted
- 21 Nov 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinico-biological Database of Lung Cancers
- ClinicalTrials.gov ID
- NCT03387865
- Acronym / sponsor ID
- Bio-lung / 2015_43
- Conditions
- Lung Cancer
- Keywords
- banking, biological sampling, tumor tissue, tumor response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille, University of Lille Nord de France
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 2 Jan 2018 (actual)
- 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.
This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.
Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes patients taken in charge at UH Lille, department of pneumology and thoracic oncology (may be also treated at thoracic surgery department, in same hospital). The subjects have a lung cancer diagnosis (all stages are eligible) or a suspicion of lung cancer ; they are included before any treatment initiation.
Key inclusion criteria (8 listed)
- Documented new diagnosis of lung cancer by histology or cytology, or lung tumor leading to lung cancer suspicion without diagnosis for which an antineoplastic treatment is indicated
- Indication of a treatment by surgery, chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy as first line of lung cancer treatment
- ability of the subject to follow study procedures
- Age > 18 years
- Subject must have at least one measurable and/or assessable lesion in regard with RECIST 1.1 criteria
Key exclusion criteria (5 listed)
- Patient with a history of treatment by antineoplastic chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy, or presenting a contra indication to antineoplastic treatment administration
- Subject is not willing to sign the informed consent form
- Subject is not registered with a social security scheme
- Subject is not francophone
- Subject is deprived of his/her liberty or under trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue biopsiesadditional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue. | Procedure or surgery | – |
| blood samplingadditional blood samples will be collected during a SOC sampling procedure (2 EDTA 7.5 ml tubes, 2 SST 7.5 ml tubes and 2 citrate 5 ml tubes) | Procedure or surgery | – |
| DNA bankingconstitutional and somatic genetic alterations will be analysed for subjects who consent, from either tumor or healthy tissue, or whole blood buffy coat after centrifugation | Genetic | – |
Primary outcome
Objective response rate assessed by CT scan
Time frame: 8 weeks
Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (partial response defined as a decrease of at least 30% in size of target lesions, complete response defined as a disappearance of all lesions)
4 secondary outcomes
Disease progression rate assessed by CT scan
Time frame: 8 weeks
Progression-free survival
Time frame: 8 weeks
Overall survival
Time frame: 1 year
treatment toxicity
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Alexis CORTOT, MD,PhD principal investigator
University Hospital, Lille
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 Lung Cancer, run by University Hospital, Lille 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis CORTOT, MD,PhD (+33320445612, alexis.cortot@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate assessed by CT scan (time frame: 8 weeks). 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 22 May 2026.