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)

NCT03017573 | Recruiting

• 1 other identifier: IC 2016-03
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation between tumor molecular/immunological profile and Baseline clinicobiological features

  up to 6 months

Secondary Outcomes (5)

• Correlation between disease recurrence and molecular and/or immunological biomarkers

  up to 24 months

• Correlation between genomic alterations and immune parameters

  up to 24 months

• Correlation between mutations load and immune parameters

  up to 24 months

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

  up to 24 months

• For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence

  up to 24 months

Study Arms (1)

Tumor and blood sampling

EXPERIMENTAL

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

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

Interventions

Tumor biopsies / Tumor surgery PROCEDURE

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)

Tumor and blood sampling

Blood withdrawal PROCEDURE

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

Tumor and blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tumor types :
• 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).
• Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment
• Male or female patients ≥ 18 years of age
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (6)

Institut Bergonie

Bordeaux, 33076, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Institut Curie Hopital Rene Huguenin

Saint-Cloud, 92210, France

RECRUITING

Institut de Cancérologie de Lorraine - Nancy

Vandœuvre-lès-Nancy, France

NOT YET RECRUITING

Related Publications (1)

• Hoffmann C, Noel F, Grandclaudon M, Massenet-Regad L, Michea P, Sirven P, Faucheux L, Surun A, Lantz O, Bohec M, Ye J, Guo W, Rochefort J, Klijanienko J, Baulande S, Lecerf C, Kamal M, Le Tourneau C, Guillot-Delost M, Soumelis V. PD-L1 and ICOSL discriminate human Secretory and Helper dendritic cells in cancer, allergy and autoimmunity. Nat Commun. 2022 Apr 13;13(1):1983. doi: 10.1038/s41467-022-29516-w.

  PMID: 35418195 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Triple Negative Breast Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Sarcoma; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Vulvar Diseases

Study Officials

• Edith BORCOMAN, Prof.

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie PLISSONNIER

CONTACT

01 47 11 23 78; drci.promotion@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: January 6, 2017
• Primary Completion (Estimated): August 6, 2029
• Study Completion (Estimated): January 6, 2032
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (6)