Prospective Biobanking Study in Ovarian, Breast and Head and Neck Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Sponsor

Institut Curie (Other)

Overall Status

Recruiting

CT.gov ID

NCT03017573

Collaborator

(none)

700

Enrollment

Locations

Arm

143.8

Anticipated Duration (Months)

350

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast and head and neck cancer patients. 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Triple-Negative Breast Cancer Head and Neck Cancer	Procedure: Tumor biopsies / Tumor surgery Procedure: Blood withdrawal	N/A

Detailed Description

Patients will have blood and +/- tumor samples at the following times :

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)

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Prospective Biobanking Study in Ovarian, Breast and Head and Neck Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response

Actual Study Start Date :

Jan 6, 2017

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tumor and blood sampling Patients will have a biopsy or a surgery and blood sampling at different time points.	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 after 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 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

Arm

Intervention/Treatment

Experimental: Tumor and blood sampling

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

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 after 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 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Paris		France	75005
2	Institut Curie Hopital Rene Huguenin	Saint-cloud		France	92210

Sponsors and Collaborators

Institut Curie

Investigators

Principal Investigator: Christophe LE TOURNEAU, Prof., Institut Curie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Curie

ClinicalTrials.gov Identifier:

NCT03017573

Other Study ID Numbers:

IC 2016-03

First Posted:

Jan 11, 2017

Last Update Posted:

Jan 3, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Institut Curie

Immunological biomarkers

molecular profil

Circulating tumor DNA (ctDNA)

Additional relevant MeSH terms:

Head and Neck Neoplasms

Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Jan 3, 2022