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)

Обзор

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.

Подробное описание

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)

Вмешательства

• Процедура 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)
• Процедура 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

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 6 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT03017573 · IC 2016-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗