Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

NCT ID: NCT03302884

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2023-10-30

Brief Summary

Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

Detailed Description

The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse.

Prospective multicentre open-label study

During visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. Tumor samples will be collected at surgery or through a biopsy.

Patients will then have a standard care follow-up for a period of 5 years.

Conditions

Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Biological sampling in ovarian carcinoma

Blood and tumor samples

Group Type: EXPERIMENTAL

biological sampling

Intervention Type: OTHER

Tumor and blood samples

Interventions

biological sampling

Tumor and blood samples

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.

2. Indication of preoperative and/or adjuvant chemotherapy.

3. Age ≥ 18 years old.

4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen

5. Signed written informed consent prior to any screening procedures being performed

1. Contraindication to surgical assessment.

2. Pathological diagnosis of mucinous carcinoma.

3. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer).

4. Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.

5. Patient in urgency situation, adult under legal protection, or unable to give his consent.

Exclusion Criteria

Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renaud SABATIER, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status: RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status: RECRUITING

Institut Du Cancer de Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

DOMINIQUE GENRE, MD

Role: CONTACT

drci.up@ipc.unicancer.fr

33 4 91 22 37 78

Margot BERLINE, MSc, MBA

Role: CONTACT

drci.up@ipc.unicancer.fr

33 4 91 22 37 78

Facility Contacts

Christophe POMEL, MD

Role: primary

Fabrice NARDUCCI, MD

Role: primary

Pierre-Emmanuel COLOMBO, MD

Role: primary

Related Links

http://www.institutpaolicalmettes.fr

Description official web site of the sponsor

Other Identifiers

CIDOC-IPC- 2016-008

Identifier Type: -

Identifier Source: org_study_id