A Clinico-biological Database of Lung Cancers

Study Overview
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Brief Summary
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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.

Official Title
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A Clinico-biological Database of Lung Cancers

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: tissue biopsies
* Procedure: blood sampling
* Genetic: DNA banking


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: tissue biopsies|additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.|
|Procedure: 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|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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banking, biological sampling, tumor tissue, tumor response