A Clinico-biological Database of Lung Cancers

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT03387865
• Lead Sponsor: University Hospital, Lille

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2018-01-02
• Study Start: 2019-03-13
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19
• Primary Completion: 2032-03
• Study Completion: 2032-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate assessed by CT scan	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Calmette, CHU; 🇫🇷 Lille, France