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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)

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)

Recruiting
18 years and older
All
Phase N/A

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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 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.

Description

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)

Eligibility

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 cervical cancer patients (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).
  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

Study details
    Ovarian Cancer
    Triple-Negative Breast Cancer
    Head and Neck Cancer
    Cervical Cancer

NCT03017573

Institut Curie

17 April 2024

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