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

Not Applicable

Recruiting

• Conditions: Ovarian Cancer; Head and Neck Cancer; Triple-Negative Breast Cancer; Cervical Cancer
• Interventions: Procedure: Tumor biopsies / Tumor surgery; Procedure: Blood withdrawal

• Registration Number: NCT03017573
• Lead Sponsor: Institut Curie

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 and Cervical 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.

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)

Study Timeline

• Study Start: 2017-01-06
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2028-08
• Study Completion: 2031-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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).

2. Male or female patients ≥ 18 years of age

3. Signed informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor and blood sampling	Blood withdrawal	Patients will have a biopsy or a surgery and blood sampling at different time points.
Tumor and blood sampling	Tumor biopsies / Tumor surgery	Patients will have a biopsy or a surgery and blood sampling at different time points.

Primary Outcome Measures

Name	Time	Method
Correlation between tumor molecular/immunological profile and Baseline clinicobiological features	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Correlation between ctDNA levels, de novo mutations in ctDNA and immune	up to 24 months
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
For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence	up to 24 months

Trial Locations

Locations (5)

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Curie Hopital Rene Huguenin; 🇫🇷 Saint-cloud, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Institut Curie; 🇫🇷 Paris, France