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

September 25, 2019 updated by: Institut Paoli-Calmettes
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont Ferrand, France, 63011
        • Recruiting
        • Centre Jean Perrin
        • Contact:
          • Christophe POMEL, MD
      • Lille, France, 59000
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Fabrice NARDUCCI, MD
      • Montpellier, France, 34298
        • Recruiting
        • Institut du Cancer de Montpellier
        • Contact:
          • Pierre-Emmanuel Colombo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Non inclusion Criteria:

  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 after histological exam:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological sampling in ovarian carcinoma
Blood and tumor samples
Other: biological sampling
Tumor and blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse.
Time Frame: at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years
Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir
at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Renaud Sabatier, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDOC-IPC- 2016-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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