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A Clinico-biological Database of Lung Cancers (Bio-lung)

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ClinicalTrials.gov Identifier: NCT03387865
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Institut Pasteur de Lille
University of Lille Nord de France
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment
Lung Cancer Procedure: tissue biopsies Procedure: blood sampling Genetic: DNA banking

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Clinico-biological Database of Lung Cancers
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • 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 :
  1. Objective response rate assessed by CT scan [ Time Frame: 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 Outcome Measures :
  1. Disease progression rate assessed by CT scan [ Time Frame: 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)

  2. Progression-free survival [ Time Frame: 8 weeks ]
  3. Overall survival [ Time Frame: 1 year ]
    number of subjects alive

  4. treatment toxicity [ Time Frame: 8 weeks ]
    length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4


Other Outcome Measures:
  1. Variation of patient-reported ICEC-R (randomised clinical trials comprehension inventory) [ Time Frame: 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)

  2. Variation of CARE (Consultation and Relational Empathy) questionnaires [ Time Frame: 8 weeks ]
    This mesure evaluate between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)


Biospecimen Retention:   Samples With DNA
serum, plasma, tumor tissue, healthy tissue, stools (gut microbiome)


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387865


Contacts
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Contact: Alexis CORTOT, MD,PhD +33320445612 alexis.cortot@chru-lille.fr
Contact: Eric WASIELEWSKI, M +33320445612 eric.wasielewski@chru-lille.fr

Locations
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France
Hôpital Calmette, CHU Recruiting
Lille, France
Principal Investigator: Alexis Cortot, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Institut Pasteur de Lille
University of Lille Nord de France
Investigators
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Principal Investigator: Alexis CORTOT, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03387865     History of Changes
Other Study ID Numbers: 2015_43
2016-A01383-48 ( Other Identifier: ID-RCB number, ANSM )
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
banking, biological sampling, tumor tissue, tumor response
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases