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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)

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03017573
Acronym
SCANDARE
Enrollment
1050
Registered
2017-01-11
Start date
2017-01-06
Completion date
2032-01-06
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Head and Neck Cancer, Ovarian Cancer, Sarcoma, Triple-Negative Breast Cancer, Vulva Cancer

Keywords

Immunological biomarkers, molecular profil, Circulating tumor DNA (ctDNA)

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)

Interventions

PROCEDURETumor biopsies / Tumor 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)

PROCEDUREBlood withdrawal

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

Sponsors

Institut Curie
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Correlation between tumor molecular/immunological profile and Baseline clinicobiological featuresup to 6 months

Secondary

MeasureTime frame
Correlation between disease recurrence and molecular and/or immunological biomarkersup to 24 months
Correlation between genomic alterations and immune parametersup to 24 months
Correlation between mutations load and immune parametersup to 24 months
Correlation between ctDNA levels, de novo mutations in ctDNA and immuneup to 24 months
For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrenceup to 24 months

Countries

France

Contacts

CONTACTAnne-Sophie PLISSONNIER
drci.promotion@curie.fr01 47 11 23 78
PRINCIPAL_INVESTIGATOREdith BORCOMAN, Prof.

Institut Curie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026