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

Primary Purpose

Ovarian Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological sampling
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ovarian Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Jean PerrinRecruiting
  • Centre Oscar LambretRecruiting
  • Institut Du Cancer de MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological sampling in ovarian carcinoma

Arm Description

Blood and tumor samples

Outcomes

Primary Outcome Measures

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.
Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir

Secondary Outcome Measures

Full Information

First Posted
October 2, 2017
Last Updated
September 25, 2019
Sponsor
Institut Paoli-Calmettes
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03302884
Brief Title
Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Acronym
CIDOC
Official Title
Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological sampling in ovarian carcinoma
Arm Type
Experimental
Arm Description
Blood and tumor samples
Intervention Type
Other
Intervention Name(s)
biological sampling
Intervention Description
Tumor and blood samples
Primary Outcome Measure Information:
Title
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.
Description
Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy. Indication of preoperative and/or adjuvant chemotherapy. Age ≥ 18 years old. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen Signed written informed consent prior to any screening procedures being performed Non inclusion Criteria: Contraindication to surgical assessment. Pathological diagnosis of mucinous carcinoma. 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). Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DOMINIQUE GENRE, MD
Phone
33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margot BERLINE, MSc, MBA
Phone
33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud SABATIER, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe POMEL, MD
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice NARDUCCI, MD
Facility Name
Institut Du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel COLOMBO, MD

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr
Description
Description official web site of the sponsor

Learn more about this trial

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

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