A Clinico-biological Database of Lung Cancers

NCT03387865 | Recruiting

• 2 other identifiers: 2015_432016-A01383-48
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

banking, biological sampling, tumor tissue, tumor response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease progression rate assessed by CT scan

  8 weeks

• Progression-free survival

  8 weeks

• Overall survival

  1 year

• treatment toxicity

  8 weeks

Other Outcomes (2)

• Variation of patient-reported ICEC-R (randomised clinical trials comprehension inventory)

  8 weeks

• Variation of CARE (Consultation and Relational Empathy) questionnaires

  8 weeks

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut Pasteur de Lille: collaborator
• University of Lille Nord de France: collaborator

Study Sites (1)

Hôpital Calmette, CHU

Lille, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, tumor tissue, healthy tissue, stools (gut microbiome)

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Blood Specimen Collection; Gene Library

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Genetic Structures; Genetic Phenomena

Study Officials

• Alexis CORTOT, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis CORTOT, MD,PhD

CONTACT

+33320445612; alexis.cortot@chru-lille.fr

Eric WASIELEWSKI, M

CONTACT

+33320445612; eric.wasielewski@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: January 2, 2018
• Study Start: March 13, 2019
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)