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

Not Applicable

Recruiting

• Conditions: Sarcomas; Haematological Malignancies

• Registration Number: NCT06829654
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

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 Timeline

• Study Start: 2024-08-12
• Status Verified: 2024-11
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-05-31
• Study Completion: 2026-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection rate of cancer cells on cryopreserved ovarian tissue	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)

Secondary Outcome Measures

Name	Time	Method
Concordance of histological/molecular investigations	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
Disease-specific detection rate	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
Ovarian contamination	through study completion, an average of 1 year	Estimate, for molecular analysis methods, the proportion of ovarian contamination by cancer cells in different pathologies

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy