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

NCT06829654 | Recruiting

• 1 other identifier: CRIOTESOVA2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcomas; Haematological Malignancies

Keywords

sarcomas; haematological malignancies; cryopreservation; ovarian tissue

Outcome Measures

Primary Outcomes (1)

• Detection rate of cancer cells on cryopreserved ovarian tissue

  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 Outcomes (3)

• Concordance of histological/molecular investigations

  through study completion, an average of 1 year

• Disease-specific detection rate

  through study completion, an average of 1 year

• Ovarian contamination

  through study completion, an average of 1 year

Study Arms (3)

Patients who request cryopreservation of ovarian tissue

OTHER

Patients who request cryopreservation of ovarian tissue

Other: Step 1; Other: Step 2; Other: Step 3

Patients with already cryopreserved ovarian tissue at the criobank

OTHER

Patients with already cryopreserved ovarian tissue at the criobank

Other: Step 2; Other: Step 3

Patients who request ovarian tissue reimplantation

OTHER

Patients who request ovarian tissue reimplantation

Other: Step 2; Other: Step 3; Other: Step 4

Interventions

Step 1 OTHER

Cryopreservation of ovarian tissue

Patients who request cryopreservation of ovarian tissue

Step 2 OTHER

Analysis of tumor markers in the primary tumor

Patients who request cryopreservation of ovarian tissue; Patients who request ovarian tissue reimplantation; Patients with already cryopreserved ovarian tissue at the criobank

Step 3 OTHER

Search for neoplastic cells in cryopreserved ovarian tissue

Patients who request cryopreservation of ovarian tissue; Patients who request ovarian tissue reimplantation; Patients with already cryopreserved ovarian tissue at the criobank

Step 4 OTHER

Cryopreserved ovarian tissue autotransplantation

Patients who request ovarian tissue reimplantation

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

SE 1-step Futurabond M

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Renato Seracchioli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Seracchioli, MD

CONTACT

+390512143944; renato.seracchioli@aosp.bo.it

Rossella Vicenti

CONTACT

rossella.vicenti@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 17, 2025
• Study Start: August 12, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: February 17, 2025

Record last verified: 2024-11

Locations

IT (1)