Cryopreserved Ovarian Tissue Transplantation in Patients Who Have Survived Sarcomas and Hematological Tumors

February 11, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors

The study aims to test for the presence or absence of primary tumor-specific tumor markers in ovarian tissue. Therefore, there will be a first phase in which pathology-specific markers will be identified in the patients' diagnostic pathological material by histological, immunohistochemical, and molecular analysis; then, tumor markers will be sought in cryopreserved ovarian tissue.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Standardized strategies for detecting neoplastic cells in ovarian tissue of patients with prior sarcomas or oncohematologic malignancies are not available. To increase the safety of ovarian tissue transplantation, the use of advanced and highly sensitive molecular approaches could greatly improve the detection of malignant cells in ovarian tissue.

The study aims to test for the presence or absence of primary tumor-specific tumor markers in ovarian tissue. Therefore, there will be a first phase in which pathology-specific markers will be identified in the patients' diagnostic pathological material by histological, immunohistochemical, and molecular analysis; then, tumor markers will be sought in cryopreserved ovarian tissue.

Identifying highly sensitive molecular tests would lead to increased safety of transplantation in patients cured of sarcomas and oncohematologic diseases. Overall, applications of the techniques under study would increase the chances of resolving infertility, which often reduces the quality of life of these patients, by offering them the chance to procreate and have biological children. The hope of motherhood is an important psychological support and can greatly help patients cope with the difficult treatment process while minimizing social/psychological support. In the long journey of treatment to defeat the disease, being able to offer an option to at least combat the fear of losing endocrine and reproductive function can have a profound impact not only on the patients themselves, but on the entire family and non-family environment.

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For all groups:

  • Patients with Ewing (ES) and synovial (SS) sarcoma, acute lymphoblastic leukemia (LLA), acute myeloid leukemia (LMA), chronic myeloid leukemia (LMC) and myelodysplasia (MDS)
  • No objection to the procedure of sampling for cryopreservation or reimplantation of ovarian tissue by the patient's reference oncologist (according to PA105)
  • Obtaining informed consent.

Group 1:

  • Age >18 and under 38 at the time of cryopreservation
  • Request for cryopreservation of ovarian tissue at the Laboratory Cryopreservation Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO

Group 2:

  • Age >18 years
  • Ovarian tissue already collected and cryopreserved at the Laboratory for Cryopreservation of Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO

Group 3

  • Age > 18 years
  • Request for reimplantation of cryopreserved ovarian tissue at the Laboratory for Cryopreservation of Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO
  • Early menopause or menstrual irregularities

Exclusion Criteria:

Group 1 and 3

  • Contraindications to laparoscopy
  • HIV, hepatitis B and C, treponema pallidum and positive PAP tests
  • Malignant disease involving the ovary or samples to be reimplanted

Group 2 None.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients who request cryopreservation of ovarian tissue
Other: Step 1
Cryopreservation of ovarian tissue
Other: Step 2
Analysis of tumor markers in the primary tumor
Other: Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Other: Patients with already cryopreserved ovarian tissue at the criobank
Other: Step 2
Analysis of tumor markers in the primary tumor
Other: Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Other: Patients who request ovarian tissue reimplantation
Other: Step 2
Analysis of tumor markers in the primary tumor
Other: Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Other: Step 4
Cryopreserved ovarian tissue autotransplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of cancer cells on cryopreserved ovarian tissue
Time Frame: through study completion, an average of 1 year
Detection rate of cancer cells on cryopreserved ovarian tissue for a diagnostic panel specific to pathology in anamnesis, patients with Ewing sarcoma (SE), synovial sarcoma (SS), acute lymphoblastic leukemia (LLA), acute myeloid leukemia (AML), chronic myeloid leukemia (CML) or myelodysplasia (MDS)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of histological/molecular investigations
Time Frame: through study completion, an average of 1 year
Establish the correlation between histological-immunohistochemicals investigations and molecular investigations and between molecular investigations in identifying neoplastic cells in cryopreserved ovarian tissue
through study completion, an average of 1 year
Disease-specific detection rate
Time Frame: through study completion, an average of 1 year
Identify the diagnostic method with the highest detection rate for each pathology analyzed, including histo-immunohistochemical investigations and molecular investigations
through study completion, an average of 1 year
Ovarian contamination
Time Frame: through study completion, an average of 1 year
Estimate, for molecular analysis methods, the proportion of ovarian contamination by cancer cells in different pathologies
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Renato Seracchioli, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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 12, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

August 12, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIOTESOVA2024

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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