Clinico-biological Data Collection Study of Metastatic Lung Cancer

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Cancerologie de l'Ouest

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample and questionnaires

18 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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Metastasis biopsy

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: FollowOther 1 intervention

Trial outcomes

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

Time frame
15 years

Secondary outcomes

1

To describe response to treatment for each therapeutic sequence

The response to treatment will be assessed using local radiological review according to RECIST 1.1 criteria

Time frame
15 years
2

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

Progression Free survival is defined by the delay between the first dose of a treatment sequence and the date of documented disease progression or death

Time frame
15 years

Other outcomes

Sponsors and contacts

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