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

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: Lung Cancer
• Intervention / Treatment: Procedure: tissue biopsies; Procedure: blood sampling; Genetic: DNA banking

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Alexis CORTOT, MD,PhD; Phone Number: +33320445612; Email: alexis.cortot@chru-lille.fr
• Study Contact Backup: Name: Eric WASIELEWSKI, M; Phone Number: +33320445612; Email: eric.wasielewski@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Calmette, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

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	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	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		8 weeks
Overall survival	number of subjects alive	1 year
treatment toxicity	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)	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	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

• Sponsor: University Hospital, Lille
• Collaborators: Institut Pasteur de Lille; University of Lille Nord de France

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Anticipated): March 1, 2032
• Study Completion (Anticipated): 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): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: banking, biological sampling, tumor tissue, tumor response
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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