Clinical trial NCT03387865: A Clinico-biological Database of Lung Cancers
Official title: A Clinico-biological Database of Lung Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: banking, biological sampling, tumor tissue, tumor response
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
name: University of Lille Nord de France
First posted: 2018-01-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate assessed by CT scan
timeFrame: 8 weeks
Secondary outcomes:
measure: Disease progression rate assessed by CT scan
timeFrame: 8 weeks
measure: Progression-free survival
timeFrame: 8 weeks
measure: Overall survival
timeFrame: 1 year
measure: treatment toxicity
timeFrame: 8 weeks
Other outcomes:
measure: Variation of patient-reported ICEC-R (randomised clinical trials comprehension inventory)
timeFrame: 8 weeks
measure: Variation of CARE (Consultation and Relational Empathy) questionnaires
timeFrame: 8 weeks
Locations:
city: Lille
country: France
facility: Hôpital Calmette, CHU
Study officials:
affiliation: University Hospital, Lille
name: Alexis CORTOT, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: