- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02900625
Validation of a Method to Search Residual Disease in Auto-cryopreserved Ovarian Tissues (VMRDO)
January 26, 2021 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 Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) 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.
The investigators 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
Study Type
Observational
Enrollment (Anticipated)
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
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Besançon, France, 25030
- CHRU Besançon
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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
Ovarian cortex residues, coming from the preparation of ovarian cortex fragments, will be used as study material for research of the Minimal Residual Disease (MRD).
Tissues will be obtained in patients candidates for cryopreservation of ovarian tissue before their gonadotoxic treatment against acute leukemia.
Description
Inclusion Criteria:
- Patients who have cryopreserved their ovarian tissue
- Patients with premature ovarian insufficiency
- Patient aged from 18 to 43 years for the restoration of ovarian function
- No objection from the patient
Exclusion Criteria:
- Patients Under 18 years
- Patients older than 43 years
- Patients refusing to be included
- Patients (adults) Under guardianship, curators ans 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 |
---|---|
Number of leukemia cells in ovarian cortex
Time Frame: 5 years
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5 years
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Number of leukemia cells expressed in function of total cell number living analyzed multicolor flow cytometry
Time Frame: 5 years
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.
- Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.
- Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.
- Zver T, Alvergnas-Vieille M, Garnache-Ottou F, Ferrand C, Roux C, Amiot C. Minimal residual disease detection in cryopreserved ovarian tissue by multicolor flow cytometry in acute myeloid leukemia. Haematologica. 2014 Dec;99(12):e249-52. doi: 10.3324/haematol.2014.113373. Epub 2014 Sep 19. No abstract available.
- Zver T, Alvergnas-Vieille M, Garnache-Ottou F, Roux C, Amiot C. A new method for evaluating the risk of transferring leukemic cells with transplanted cryopreserved ovarian tissue. J Assist Reprod Genet. 2015 Aug;32(8):1263-6. doi: 10.1007/s10815-015-0512-4. Epub 2015 Jul 3.
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)
May 1, 2013
Primary Completion (ACTUAL)
May 1, 2020
Study Completion (ACTUAL)
May 1, 2020
Study Registration Dates
First Submitted
August 30, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (ESTIMATE)
September 14, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- API/2011/22
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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