Actively Recruiting

Phase Not Applicable
Age: 18Years - 38Years
FEMALE
ID06829654

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-17

80

Participants Needed

1

Research Sites

10 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the presence or absence of primary tumor-specific markers in ovarian tissue of patients who have survived sarcomas or hematological cancers. The goal is to improve the safety of ovarian tissue transplantation by identifying highly sensitive molecular tests that detect malignant cells. This research aims to help patients overcome infertility caused by cancer treatments and improve their quality of life by offering the chance to have biological children. The study involves several steps: first, cryopreservation of ovarian tissue is performed. Next, tumor markers are identified in the patients' original tumor samples using histological, immunohistochemical, and molecular analysis. Then, these markers are searched for in the cryopreserved ovarian tissue. Finally, ovarian tissue autotransplantation is done if appropriate. This process is done across different patient groups, including those requesting cryopreservation, those with already cryopreserved tissue, and those requesting reimplantation. Participants will undergo tissue sampling and various laboratory tests to detect cancer cells in ovarian tissue over about one year. Researchers will evaluate detection rates of cancer cells and compare histological and molecular findings. Monitoring includes assessing ovarian contamination and disease-specific detection rates. The study is non-randomized and open-label, and participants are followed through the completion of the study period to assess safety and outcomes related to ovarian tissue transplantation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 38Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with Ewing or synovial sarcoma, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia, or myelodysplasia
  • No objection from the patient's oncologist for ovarian tissue sampling or reimplantation
  • Signed informed consent obtained
  • Group 1: Female patients aged over 18 and under 38 requesting ovarian tissue cryopreservation
  • Group 2: Female patients aged over 18 with ovarian tissue already cryopreserved at the study criobank
  • Group 3: Female patients aged over 18 requesting reimplantation of cryopreserved ovarian tissue with early menopause or menstrual irregularities
Not Eligible

You will not qualify if you...

  • Groups 1 and 3: Contraindications to laparoscopy
  • Groups 1 and 3: Positive tests for HIV, hepatitis B or C, treponema pallidum, or positive PAP tests
  • Groups 1 and 3: Malignant disease involving the ovary or samples to be reimplanted
  • Group 2: No exclusion criteria listed

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Cryopreservation and Tumor Marker Analysis

Duration - Variable depending on individual procedures

Participants undergo ovarian tissue cryopreservation followed by analysis of tumor markers in their primary tumor and cryopreserved ovarian tissue.

1 to 2 visits depending on procedures

Cryopreserved Ovarian Tissue Autotransplantation

Duration - Until ovarian tissue transplantation is completed

Participants who request reimplantation undergo autotransplantation of their cryopreserved ovarian tissue.

1 visit for transplantation; follow-up visits as needed

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

R

Renato Seracchioli, MD

R

Rossella Vicenti

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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