Cryopreserved Ovarian Tissue Transplantation in Patients Who Have Survived Sarcomas and Hematological Tumors
NCT ID: NCT06829654
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-08-12
2026-08-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients who request cryopreservation of ovarian tissue
Patients who request cryopreservation of ovarian tissue
Step 1
Cryopreservation of ovarian tissue
Step 2
Analysis of tumor markers in the primary tumor
Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Patients with already cryopreserved ovarian tissue at the criobank
Patients with already cryopreserved ovarian tissue at the criobank
Step 2
Analysis of tumor markers in the primary tumor
Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Patients who request ovarian tissue reimplantation
Patients who request ovarian tissue reimplantation
Step 2
Analysis of tumor markers in the primary tumor
Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Step 4
Cryopreserved ovarian tissue autotransplantation
Interventions
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Step 1
Cryopreservation of ovarian tissue
Step 2
Analysis of tumor markers in the primary tumor
Step 3
Search for neoplastic cells in cryopreserved ovarian tissue
Step 4
Cryopreserved ovarian tissue autotransplantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
38 Years
FEMALE
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Principal Investigators
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Renato Seracchioli, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRIOTESOVA2024
Identifier Type: -
Identifier Source: org_study_id
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