A Clinico-biological Database of Lung Cancers

Lung Cancer Clinical Trial

— Bio-lung  

Official title:

A Clinico-biological Database of Lung Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03387865
• Other study ID #: 2015_43
• Secondary ID: 2016-A01383-48
• Status: Recruiting
• Start date: March 13, 2019
• Est. completion date: March 2032

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: Alexis CORTOT, MD,PhD
• Phone: +33320445612
• Email: alexis.cortot[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2032
• Est. primary completion date: March 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• tissue biopsies
additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.
• blood sampling
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)

Genetic:
• DNA banking
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

Locations

Country	Name	City	State
France	Hôpital Calmette, CHU	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut Pasteur de Lille, University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	Progression-free survival		8 weeks
Secondary	Overall survival	number of subjects alive	1 year
Secondary	treatment toxicity	length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4	8 weeks