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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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).

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tumor biopsies / Tumor surgery

    Procedure/Surgery

    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 withdrawal

    Procedure/Surgery

    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

Treatment groups

1,050 Participants
are divided into 1 treatment group
Group A: Tumor and blood samplingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Correlation between tumor molecular/immunological profile and Baseline clinicobiological features

Time frame
up to 6 months

Secondary outcomes

1

Correlation between disease recurrence and molecular and/or immunological biomarkers

Time frame
up to 24 months
2

Correlation between genomic alterations and immune parameters

Time frame
up to 24 months
3

Correlation between mutations load and immune parameters

Time frame
up to 24 months
4

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

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

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