Official Title
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)
Brief Title
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)
Protocol ID
NCT03017573
Lead Sponsor
Institut Curie
Brief Summary
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.
Detailed 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)
Study Period
-
Enrollment Count
1,050 participants
Eligibility Criteria
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
Filters
Ovarian Cancer
Triple-Negative Breast Cancer
Head and Neck Cancer
Cervical Cancer
Sarcoma
Vulva Cancer
NA
RECRUITING
ADULT
OLDER_ADULT