RecruitingNot ApplicableNCT04944030

Clinico-biological Data Collection Study of Metastatic Lung Cancer

Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients


Sponsor

Institut Cancerologie de l'Ouest

Enrollment

200 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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

Exclusion Criteria5

  • 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

Interventions

PROCEDUREMetastasis biopsy

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.


Locations(2)

Institut de Cancerologie de L'Ouest

Angers, France

Institut de Cancerologie de L'Ouest

Saint-Herblain, France

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NCT04944030


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