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)

Ovarian Cancer Clinical Trial

— SCANDARE  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03017573
• Other study ID #: IC 2016-03
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2017
• Est. completion date: January 6, 2031

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: Anne-Sophie PLISSONNIER
• Phone: 01 47 11 23 78
• Email: drci.promotion[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 6, 2031
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cervical Cancer
• Head and Neck Cancer
• Ovarian Cancer
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer
• Uterine Cervical Neoplasms

Intervention

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)
• 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 recurrence before first cycle of adjuvant treatment or before radiotherapy before second cycle of adjuvant treatment or after radiotherapy at progression

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Institut Curie	Paris
France	Institut Curie Hopital Rene Huguenin	Saint-cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between tumor molecular/immunological profile and Baseline clinicobiological features		up to 6 months
Secondary	Correlation between disease recurrence and molecular and/or immunological biomarkers		up to 24 months
Secondary	Correlation between genomic alterations and immune parameters		up to 24 months
Secondary	Correlation between mutations load and immune parameters		up to 24 months
Secondary	Correlation between ctDNA levels, de novo mutations in ctDNA and immune		up to 24 months
Secondary	For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence		up to 24 months