A Clinico-biological Database of Lung Cancers (Bio-lung)

May 20, 2026 updated by: University Hospital, Lille

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Calmette, CHU
        • Principal Investigator:
          • Alexis Cortot, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression rate assessed by CT scan
Time Frame: 8 weeks
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)
8 weeks
Progression-free survival
Time Frame: 8 weeks
8 weeks
Overall survival
Time Frame: 1 year
number of subjects alive
1 year
treatment toxicity
Time Frame: 8 weeks
length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of patient-reported ICEC-R (randomised clinical trials comprehension inventory)
Time Frame: 8 weeks
This mesure evaluate subject's emotional skills in regard of the clinical trial inclusion process between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)
8 weeks
Variation of CARE (Consultation and Relational Empathy) questionnaires
Time Frame: 8 weeks
This mesure evaluate between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Institut Pasteur de Lille
University of Lille Nord de France

Investigators

  • Principal Investigator: Alexis CORTOT, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_43
  • 2016-A01383-48 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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