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Clinical Trials in Italy / NCT06829654
Recruiting Not applicable

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

NCT06829654 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Not applicable
Started
2024-08-12
Last updated
2025-02-17

Condition(s) studied

SarcomasHaematological Malignancies

Investigational drug(s) / intervention(s)

Step 1Step 2Step 3Step 4

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

Study 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
FEMALE
Min age
18 Years
Max age
38 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06829654 on ClinicalTrials.gov ↗ ← All trials in Italy