Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Vaccines

At each disease progression, patient will have specific interventions :

* Metastasis biopsy
* Biomarkers blood, urine and microbiota samples
* Patient Reported Outcome (PRO)

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.

Metastasis biopsy

JUDITH RAIMBOURG, MD,PHD

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.

This prospective study will be conducted on first line metastatic lung cancer patients. Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or lung tumor if local recurrence, usual treatment protocols are often guided by the following groups:

* For group 1: SCLC (small cell lung cancer)

  * Carbo or cisplatin + etoposide chemotherapy associated to atezolizumab or durvalumab
* For group 2: NSCLC (no small cell lung cancer) without oncogenic addiction:

  * Adenocarcinoma, NOS, sarcomatoïd carcinoma or large cell carcinoma with PDL1 expression level ≥ 50%: Carbo/cisplatin + pemetrexed + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab - Adenocarcinoma, NOS, sarcomatoïde carcinoma or large cell carcinoma with PDL1 expression level \< 50%: Carbo/cisplatin + pemetrexed + pembrolizumab.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab

- Squamous cell carcinoma with PDL1 ≥ 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt - Squamous cell carcinoma with PDL1 \< 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt

• For group 3: NSCLC NSCLC (no small cell lung cancerwith oncogenic addiction (KRAS G12c/BRAFV600E/NTRK/ROS1/ALK/EGFR/RET/NTRK/HER2):

* For which TKI is indicated: TKI as long as possible
* If TKI is not indicated: doublet of chemotherapy with platinum salt +/- pembrolizumab or pembrolizumab alone for PDL1 ≥ 50% or doublet of chemotherapy +/- bevacizumab

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 3 months according to patient group. Clinical, biological, pathological, epidemiological, socio-economic and multiomic data will be collected throughout the study duration. These massive data will be used to create new algorithms in order to help clinicians to predict treatment response

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

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

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

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

Institut Cancerologie de l'Ouest

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Metastasis biopsy will be performed for multi-omic analysis

Biomarkers blood, urine and microbiota samples for multi-omic analysis

Biomarkers blood, urine and microbiota samples

Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

Patient Reported Outcome (PRO)

Mario CAMPONE, MD, PhD

Marine TIGREAT

Anne PATSOURIS, MD

Caroline FONSEGRIVE, MD

Elouen BOUGHALEM, MD

Frederic BIGOT, MD

Julie VANBOCKSTAEL, MD

Paule AUGEREAU, MD

Patrick SOULIE, MD

Sophie ABADIE LACOURTOISIE, MD

Jean Sebastien FRENEL, MD

Dominique BERTON-RIGAUD, MD

Emmanuelle BOURBOULOUX, MD

Marie ROBERT, MD

Carole GOURMELON, MD

Pauline DU RUSQUEC, MD

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 bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

This prospective study will be conducted on first line metastatic breast cancer patients.

Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or breast tumor if local recurrence, usual treatment protocols are often guided by the following groups:

* Group 1 : Patients HR (Hormon Receptor) + (E (Estrogen Receptor) + and/or PR (Progesterone Receptor) +) and HER2- (Human Epidermal Growth Factor Receptor-2)
* Group 2 : Patients HER2 + with or without HR+
* Group 3 : Patients triple negative (HR- and HER2-) Patients will receive treatments as per standard care according to the patient group.

Standard treatments recommended for treatment first line are:

1. For group 1 : For HR + and HER2- patients :

   * For patients requiring Chemotherapy (visceral crisis), the recommended treatment is : Taxanes based chemotherapy Anthracyclines based chemotherapy
   * For the patients without visceral crisis: the recommended treatment is : Hormonal therapy combined with CDK 4-6 inhibitors (Cyclin-dependent kinase) as recommended in standard care.
2. For group 2 : HER2 + (with or without HR+), the recommended treatment is :

   * Paclitaxel (Taxol) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
   * Docetaxel (Taxotere) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
3. For group 3 : triple negative (HR- and HER2-) patients, the recommended treatment is :

   * Paclitaxel (Taxol) with or without Bevacizumab (Avastin) as per the institutional standard of care.

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 6 months according to patient group.

Clinical, biological, pathological, epidemiological, socio-economic and multi-omic data will be collected throughout the study duration.

These massive data will be used to create new algorithms in order to help clinicians to predict treatment response.

monocentric, open, prospective database with specific biopsy and blod collections done (biocollection)

Clinico-biological Data Collection Study of Metastatic Breast Cancer

Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients

search of algorithms combining multiple data (clinical, biological, imaging) in breast cancer management

Overall Survival is the delay between the date of inclusion and the date of death or last follow-up assessment if censored.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinico-biological Data Collection Study of Metastatic Lung Cancer	NCT04944030	Lung Cancer	Metastasis biop...	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Breast Cancer	NCT03958136	Breast Cancer	Metastasis biop... Biomarkers bloo... Patient Reporte...	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Lung Cancer	NCT04944030	Lung Cancer	Metastasis biop...	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Breast Cancer	NCT03958136	Breast Cancer	Metastasis biop... Biomarkers bloo... Patient Reporte...	18 Years -	Institut Cancerologie de l'Ouest

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