SarcomasNCT06829654
Cryopreserved Ovarian Tissue Transplantation in Patients Who Have Survived Sarcomas and Hematological Tumors
A study testing Step 1, Step 2 and Step 3 in people with Sarcomas and Haematological Malignancies, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Sarcomas, Haematological Malignancies
- What is being tested?
- Step 1, Step 2 and Step 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 12 Aug 2024to 12 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rossella Vicenti contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Renato Seracchioli, MD, +390512143944, renato.seracchioli@aosp.bo.it
Rossella Vicenti, rossella.vicenti@unibo.it
About this study
Official title: Safety Assessment Of 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.
Read the detailed description
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.
- Conditions
- Sarcomas, Haematological Malignancies
- Being tested
- Step 1, Step 2, Step 3, Step 4
- Keywords
- sarcomas, haematological malignancies, cryopreservation, ovarian tissue
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1Other
Cryopreservation of ovarian tissue
Step 2Other
Analysis of tumor markers in the primary tumor
Step 3Other
Search for neoplastic cells in cryopreserved ovarian tissue
Step 4Other
Cryopreserved ovarian tissue autotransplantation
| Study group | Role | What they receive |
|---|---|---|
| Patients who request cryopreservation of ovarian tissue | Other | Patients who request cryopreservation of ovarian tissue Receives: 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 Receives: Other: Step 2; Other: Step 3 |
| Patients who request ovarian tissue reimplantation | Other | Patients who request ovarian tissue reimplantation Receives: Other: Step 2; Other: Step 3; Other: Step 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Concordance of histological/molecular investigations
Establish the correlation between histological-immunohistochemicals investigations and molecular investigations and between molecular investigations in identifying neoplastic cells in cryopreserved ovarian tissue
Measured: through study completion, an average of 1 year
Disease-specific detection rate
Identify the diagnostic method with the highest detection rate for each pathology analyzed, including histo-immunohistochemical investigations and molecular investigations
Measured: through study completion, an average of 1 year
Ovarian contamination
Estimate, for molecular analysis methods, the proportion of ovarian contamination by cancer cells in different pathologies
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start12 Aug 2024
- Primary completion31 May 2026 (estimated)
- Study completion12 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Seracchioli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829654
- Sponsor's protocol ID
- CRIOTESOVA2024
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No