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

Institut Curie1,050 enrolled

Overview

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, advanced stage treatment-naïve cervical or vulva cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. 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.

Patients will have blood and +/- tumor samples at the following times : 1. 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) 2. 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)

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

1,050

Conditions

Interventions

Tumor biopsies / Tumor surgeryPROCEDURE

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)

Blood withdrawalPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Tumor types : 1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy 2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy 3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery 4. Newly diagnosed treatment-naïve vulva cancer (all types) or cervical cancer patients with (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2). 5. Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment 2. Male or female patients ≥ 18 years of age 3. Signed informed consent Exclusion Criteria: 1. Male or female patients ≤18 years old 2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 3. Individually deprived of liberty or placed under the authority of a tutor 4. Patients not affiliated to the Social Security System

Locations (6)

Institut Bergonie

Bordeaux, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

Centre Leon Berard

Lyon, France

RECRUITING

Institut Curie

Paris, France

RECRUITING

Institut Curie Hopital Rene Huguenin

Saint-Cloud, France

RECRUITING

Institut de Cancérologie de Lorraine - Nancy

Vandœuvre-lès-Nancy, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Correlation between tumor molecular/immunological profile and Baseline clinicobiological features

Time frame: up to 6 months

Secondary Outcomes

Correlation between disease recurrence and molecular and/or immunological biomarkers

Time frame: up to 24 months

Correlation between genomic alterations and immune parameters

Time frame: up to 24 months

Correlation between mutations load and immune parameters

Time frame: up to 24 months

Correlation between ctDNA levels, de novo mutations in ctDNA and immune

Time frame: up to 24 months

For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence

Time frame: up to 24 months

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts