RecruitingNot ApplicableNCT06829654

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

80 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 38 Years

Inclusion Criteria14

  • 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 Criteria5

  • 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.

Interventions

OTHERStep 1

Cryopreservation of ovarian tissue

OTHERStep 2

Analysis of tumor markers in the primary tumor

OTHERStep 3

Search for neoplastic cells in cryopreserved ovarian tissue

OTHERStep 4

Cryopreserved ovarian tissue autotransplantation


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT06829654


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