Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Study Overview
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Brief Summary
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SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer and Cervical cancer patients. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.

Detailed Description
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Patients will have blood and +/- tumor samples at the following times : if eligible for surgery : at surgery (blood + tumor and nodes) after surgery (blood) 6 months after surgery if non recurrence (Blood) before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes if possible) before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood) at progression (blood + tumor biopsie and nodes if possible) if eligible for neoadjuvant chemotherapy : before neoadjuvant therapy (blood + tumor biopsie and nodes) during neoadjuvant therapy (post cycle 1) (blood) at the time of surgery (blood + tumor and nodes) 6 months after surgery if non recurrence (Blood) before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes) before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood) at progression (blood + tumor biopsie and nodes)

Official Title
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Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Conditions
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Ovarian Cancer, Triple-Negative Breast Cancer, Head and Neck Cancer, Cervical Cancer

Intervention / Treatment
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* Procedure: Tumor biopsies / Tumor surgery
* Procedure: Blood withdrawal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tumor types : Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery Newly diagnosed treatment-naïve cervical cancer patients (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2). Male or female patients ≥ 18 years of age Signed informed consent Exclusion Criteria: Male or female patients ≤18 years old Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Individually deprived of liberty or placed under the authority of a tutor Patients not affiliated to the Social Security System

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor and blood sampling<br>Patients will have a biopsy or a surgery and blood sampling at different time points. | Procedure: Tumor biopsies / Tumor surgery<br>* Tumoral tissues samples must be collected at different times points : at the time of surgery before first cycle of adjuvant treatment (if possible) at progression (if possible) OR before neoadjuvant therapy at the time of surgery before first cycle of adjuvant treatment (if possible) at progression (if possible)<br>Procedure: Blood withdrawal<br>* Blood samples must be collected at different times points : at the time of surgery or before the beginning of chemoradiotherapy after surgery or after chemoradiotherapy 6 months after surgery if non recurrence before first cycle of adjuvant treatment or before radiotherapy before second cycle of adjuvant treatment or after radiotherapy at progression OR before neoadjuvant therapy during neoadjuvant therapy (post cycle 1) at the time of surgery 6 months after surgery if non recurrence before first cycle of adjuvant treatment or before radiotherapy before second cycle of adjuvant treatment or after radiotherapy at progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between tumor molecular/immunological profile and Baseline clinicobiological features |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between disease recurrence and molecular and/or immunological biomarkers |  | up to 24 months | 
| Correlation between genomic alterations and immune parameters |  | up to 24 months | 
| Correlation between mutations load and immune parameters |  | up to 24 months | 
| Correlation between ctDNA levels, de novo mutations in ctDNA and immune |  | up to 24 months | 
| For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence |  | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunological biomarkers, molecular profil, Circulating tumor DNA (ctDNA)