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 Curie

Status: Enrolling

Conditions: Sarcoma; Head and Neck Cancer; Ovarian Cancer; Vulva Cancer; Triple-Negative Breast Cancer; Cervical Cancer

Treatments: Procedure: Blood withdrawal; Procedure: Tumor biopsies / Tumor surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03017573

IC 2016-03

Details and patient eligibility

About

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.

Full 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)

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,050 participants in 1 patient group

Tumor and blood sampling

Experimental group

Description:

Patients will have a biopsy or a surgery and blood sampling at different time points.

Treatment:

Procedure: Tumor biopsies / Tumor surgery

Procedure: Blood withdrawal