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NCT Number: NCT06829654

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

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.

Recruiting

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Renato Seracchioli, MD

CONTACT

[email protected]

+390512143944

Renato Seracchioli, MD

PRINCIPAL_INVESTIGATOR

Rossella Vicenti

CONTACT

[email protected]

About this study

Standardized strategies for detecting neoplastic cells in ovarian tissue of patients with prior sarcomas or oncohematologic malignancies are not available. To increase the safety of ovarian tissue transplantation, the use of advanced and highly sensitive molecular approaches could greatly improve the detection of malignant cells in ovarian tissue.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Step 1

Other

Cryopreservation of ovarian tissue

Step 2

Other

Analysis of tumor markers in the primary tumor

Step 3

Other

Search for neoplastic cells in cryopreserved ovarian tissue

Step 4

Other

Cryopreserved ovarian tissue autotransplantation

Primary outcomes

  1. Detection rate of cancer cells on cryopreserved ovarian tissue

    Time frame: 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)

Secondary outcomes

  1. Concordance of histological/molecular investigations

    Time frame: through study completion, an average of 1 year

    Establish the correlation between histological-immunohistochemicals investigations and molecular investigations and between molecular investigations in identifying neoplastic cells in cryopreserved ovarian tissue

  2. Disease-specific detection rate

    Time frame: through study completion, an average of 1 year

    Identify the diagnostic method with the highest detection rate for each pathology analyzed, including histo-immunohistochemical investigations and molecular investigations

  3. Ovarian contamination

    Time frame: through study completion, an average of 1 year

    Estimate, for molecular analysis methods, the proportion of ovarian contamination by cancer cells in different pathologies

Study contacts

Contact information is provided by the study sponsor or research team.

Renato Seracchioli, MD

CONTACT

[email protected]

+390512143944

Rossella Vicenti

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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