Transplanting cryopreserved ovarian tissue in cancer survivors
Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors
This study is testing whether ovarian tissue from cancer survivors is safe to transplant by checking for any leftover cancer cells, which could help restore their fertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06829654 on ClinicalTrials.gov |
What this trial studies
This study investigates the presence of tumor-specific markers in ovarian tissue from patients who have survived sarcomas and hematological malignancies. It involves identifying these markers through advanced histological, immunohistochemical, and molecular analyses of patients' diagnostic materials. The goal is to enhance the safety of ovarian tissue transplantation by ensuring that malignant cells are not present in the cryopreserved tissue. This could ultimately help restore fertility in patients who have undergone cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 to 38 who have survived specific types of sarcomas or hematological malignancies and have consented to the procedure.
Not a fit: Patients who are older than 38 or those who do not have cryopreserved ovarian tissue may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide cancer survivors with a safe option to restore fertility and have biological children.
How similar studies have performed: Other studies have shown promise in using similar advanced molecular techniques for detecting malignant cells in ovarian tissue, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Renato Seracchioli, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Renato Seracchioli, MD
- Email: renato.seracchioli@aosp.bo.it
- Phone: +390512143944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.