Clinico-biological Data Collection Study of Metastatic Lung Cancer

NCT04944030 | Recruiting DMC

• 1 other identifier: ICO-2020-19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment. PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

Conditions

Lung Cancer

Keywords

Lung cancer; Prospective clinico-biological database; Multi omic analysis; Prediction in silico

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall Survival is defined by the delay between the date of inclusion and the date of death or last follow-up assessment

  15 years

Secondary Outcomes (2)

• To describe response to treatment for each therapeutic sequence

  15 years

• To evaluate progression free survival (PFS) for each therapeutic sequence

  15 years

Study Arms (1)

Follow

OTHER

At each disease progression, patient will have specific interventions : * Metastasis biopsy * Biomarkers blood, urine and microbiota samples * Patient Reported Outcome (PRO)

Procedure: Metastasis biopsy

Interventions

Metastasis biopsy PROCEDURE

Metastasis biopsy will be performed for multi-omic analysis Biological/Vaccine: Biomarkers blood, urine and microbiota samples Biomarkers blood, urine and microbiota samples for multi-omic analysis Behavioral: Patient Reported Outcome (PRO) Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

Follow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample and questionnaires
• years old at time of written consent
• Patient with histologically confirmed lung cancer
• Lung cancer metastatic disease or locally advanced not eligible for local curative treatment intent
• Performance status ≤ 2 (according to WHO criteria)
• Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Patient must be affiliated to a Social Health Insurance

You may not qualify if:

• Other malignancy treated within the last 3 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
• Other neuroendocrine tumour than small cell or large cell carcinoma.
• Pregnant or nursing patient
• Individual deprived of liberty or placed under the authority of a tutor
• Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (2)

Institut de Cancerologie de L'Ouest

Angers, 49933, France

RECRUITING

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• JUDITH RAIMBOURG, MD,PHD

  judith.raimbourg@ico.unicancer.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUDITH RAIMBOURG, MD,PHD

CONTACT

0240679900; judith.raimbourg@ico.unicancer.fr

MARINE TIGREAT

CONTACT

0240679878; marine.tigreat@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 29, 2021
• Study Start: April 24, 2023
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: December 8, 2025

Record last verified: 2025-01

Locations

FR (2)