Lung Cancer
Conditions
Keywords
banking, biological sampling, tumor tissue, tumor response
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.
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
Sponsors
Institut Pasteur de Lille
University of Lille Nord de France
University Hospital, Lille
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Progression-free survival | 8 weeks | — |
| Overall survival | 1 year | number of subjects alive |
| treatment toxicity | 8 weeks | length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Variation of patient-reported ICEC-R (randomised clinical trials comprehension inventory) | 8 weeks | 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) |
| Variation of CARE (Consultation and Relational Empathy) questionnaires | 8 weeks | This mesure evaluate between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3) |
Countries
France
Contacts
Primary ContactAlexis CORTOT, MD,PhD
Backup ContactEric WASIELEWSKI, M
Outcome results
None listed