Investigating Minimal Residual Disease in Autopreserved Ovarian Tissue in Cases of Neoplastic Pathology (OVAGRAFT)

January 23, 2020 updated by: Centre Hospitalier Universitaire de Besancon
Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The main part of the ovary is preserved, as primordial and primary follicles are resistant to freezing / thawing protocols. In the absence of other techniques (in vivo maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is currently the only technique allowing fertility to be restored. Autograft is possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of any codified technique for evaluating residual disease (MRD). The team has for two years been developing and validating a technique to look for residual disease in fragments of ovarian cortex in cases of acute leukemia. This technique is based on an original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have been demonstrated in an experimental model. This model consists in using 8 color flow cytometry to look for characterizable leukemia cells added in different dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of 10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR (Real-Time Quantitative Polymerase Chain Reaction) with the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. The main objective of this project is to validate techniques that have been previously codified with different populations of leukemia cells that may be characterized. We then aim to adapt and validate this technique to look for MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis. Secondary objectives will be to implement procedures for oncological qualification of grafts in cases of malignant pathology and to consider the recommendations for using this cryopreserved ovarian tissue through the autograft technique for these indications.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

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

Study Locations

  • France
      • Besançon, France, 25030
        • CHRU Besançon

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 to 43 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients likely to re-use their cryopreserved ovarian tissue by autograft

Description

Inclusion Criteria:

  • Patients who have cryopreserved their ovarian tissue
  • Patients with premature ovarian insufficiency
  • Patients aged from 18 to 43 years for the restoration of ovarian function
  • No objection from the patient
  • Patients who have already received ovarian tissue autograft

Exclusion Criteria:

  • Patients aged Under 18 years (bone age)
  • Patients older than 43 years
  • Patient refusing to be included
  • Patients (adults) Under guardianship, curators and safeguard justice

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of MRD detected using 8 colors flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

University Hospital, Rouen
CHU de Reims
Central Hospital, Nancy, France
University Hospital, Bordeaux
University Hospital, Limoges
University Hospital, Grenoble
University Hospital, Toulouse
University Hospital, Lille
Nantes University Hospital
University Hospital, Marseille
CMCO SIHCUS, Schiltingheim

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.

General Publications

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)

August 1, 2013

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

September 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2012/154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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