Clinical trial NCT03017573: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Triple-Negative Breast Cancer
Head and Neck Cancer
Cervical Cancer
Sarcoma
Keywords: Immunological biomarkers
molecular profil
Circulating tumor DNA (ctDNA)
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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)

Eligibility criteria: 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 cervical cancer patients (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

Primary outcomes:
measure: Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
timeFrame: up to 6 months
Secondary outcomes:
measure: Correlation between disease recurrence and molecular and/or immunological biomarkers
timeFrame: up to 24 months
measure: Correlation between genomic alterations and immune parameters
timeFrame: up to 24 months
measure: Correlation between mutations load and immune parameters
timeFrame: up to 24 months
measure: Correlation between ctDNA levels, de novo mutations in ctDNA and immune
timeFrame: up to 24 months
measure: For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Institut Curie
city: Saint-cloud
country: France
facility: Institut Curie Hopital Rene Huguenin
Study officials:
affiliation: Institut Curie
name: Christophe LE TOURNEAU, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.