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NCT Number: NCT03387865

A Clinico-biological Database of Lung Cancers

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Calmette, CHU

Lille, France

Location status: Recruiting

Location contact

Alexis Cortot, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis CORTOT, MD,PhD

CONTACT

[email protected]

+33320445612

Eric WASIELEWSKI, M

CONTACT

[email protected]

+33320445612

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Institut Pasteur de Lille
  • University of Lille Nord de France

Registry information

Acronym: Bio-lung

Important dates

Study start
2019
Primary completion
2032
Study completion
2032
First posted
Jan 2, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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