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)

Overview

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

• Procedure Tumor 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)
• Procedure Blood 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

Primary outcome measures

• Correlation between tumor molecular/immunological profile and Baseline clinicobiological features [Time frame: up to 6 months]

Secondary outcome measures (5)

• Correlation between disease recurrence and molecular and/or immunological biomarkers [Time frame: up to 24 months]
• Correlation between genomic alterations and immune parameters [Time frame: up to 24 months]
• Correlation between mutations load and immune parameters [Time frame: up to 24 months]
• Correlation between ctDNA levels, de novo mutations in ctDNA and immune [Time frame: up to 24 months]
• For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence [Time frame: up to 24 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 6 centers

• Institut Bergonie — Bordeaux
• Centre Oscar Lambret — Lille
• Centre Leon Berard — Lyon
• Institut Curie — Paris
• Institut Curie Hopital Rene Huguenin — Saint-Cloud
• Institut de Cancérologie de Lorraine - Nancy — Vandœuvre-lès-Nancy

Publications

• Marret G, Lamy C, Vacher S, Cabel L, Sene M, Ahmanache L, Courtois L, El Beaino Z, Klijanienko J, Martinat C, Servant N, Kamoun C, Halladjian M, Bronzini T, Balsat C, Laes JF, Prevot A, Sauvage S, Lienard M, Martin E, Genin B, Badois N, Lesnik M, Dubray-Vautrin A, Choussy O, Ghanem W, Taouachi R, Planchon JM, Bieche I, Le Tourneau C, Kamal M. Deciphering molecular relapse and intra-tumor heterogen PMID 39612700
• 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/s41467-022-2 PMID 35418195

Identifiers

NCT: NCT03017573 · IC 2016-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗