Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01383-48 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut Pasteur de Lille | OTHER |
| University of Lille Nord de France | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tissue biopsies | Procedure | additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue. | ||
| blood sampling | Procedure | 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) | ||
| DNA banking | Genetic | 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexis CORTOT, MD,PhD | Contact | +33320445612 | alexis.cortot@chru-lille.fr | |
| Eric WASIELEWSKI, M | Contact | +33320445612 | eric.wasielewski@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alexis CORTOT, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Calmette, CHU | Recruiting | Lille | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D015723 | Gene Library |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
serum, plasma, tumor tissue, healthy tissue, stools (gut microbiome)
| 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 |
| 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 |
| D012140 |
| Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |