RecruitingNCT03387865

A Clinico-biological Database of Lung Cancers

Sponsor

University Hospital, Lille

Enrollment

500 participants

Start Date

Mar 13, 2019

Study Type

OBSERVATIONAL

Conditions

Lung Cancer

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.

Eligibility

Inclusion Criteria8

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 Criteria5

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

Interventions

PROCEDUREtissue biopsies

additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.

PROCEDUREblood 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)

GENETICDNA 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