A Clinico-biological Database of Lung Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tissue biopsies, blood sampling, DNA banking.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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
Primary outcome measures
- Objective response rate assessed by CT scan [Time frame: 8 weeks]
Secondary outcome measures (4)
- Disease progression rate assessed by CT scan [Time frame: 8 weeks]
- Progression-free survival [Time frame: 8 weeks]
- Overall survival [Time frame: 1 year]
- treatment toxicity [Time frame: 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Hôpital Calmette, CHU — Lille
Identifiers
NCT: NCT03387865 · 2015_43 · 2016-A01383-48