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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors
- ClinicalTrials.gov ID
- NCT06829654
- Acronym / sponsor ID
- CRIOTESOVA2024
- Conditions
- Sarcomas, Haematological Malignancies
- Keywords
- sarcomas, haematological malignancies, cryopreservation, ovarian tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 12 Aug 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients who request cryopreservation of ovarian tissue | Other | Other: Step 1, Other: Step 2, Other: Step 3Patients who request cryopreservation of ovarian tissue |
| Patients with already cryopreserved ovarian tissue at the criobank | Other | Other: Step 2, Other: Step 3Patients with already cryopreserved ovarian tissue at the criobank |
| Patients who request ovarian tissue reimplantation | Other | Other: Step 2, Other: Step 3, Other: Step 4Patients who request ovarian tissue reimplantation |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1Cryopreservation of ovarian tissue | Other | Patients who request cryopreservation of ovarian tissue |
| Step 2Analysis of tumor markers in the primary tumor | Other | Patients who request cryopreservation of ovarian tissue, Patients who request ovarian tissue reimplantation, Patients with already cryopreserved ovarian tissue at the criobank |
| Step 3Search for neoplastic cells in cryopreserved ovarian tissue | Other | Patients who request cryopreservation of ovarian tissue, Patients who request ovarian tissue reimplantation, Patients with already cryopreserved ovarian tissue at the criobank |
| Step 4Cryopreserved ovarian tissue autotransplantation | Other | Patients who request ovarian tissue reimplantation |
Primary outcome
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)
3 secondary outcomes
Concordance of histological/molecular investigations
Time frame: through study completion, an average of 1 year
Disease-specific detection rate
Time frame: through study completion, an average of 1 year
Ovarian contamination
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rossella Vicenti contact
Renato Seracchioli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renato Seracchioli, MD (+390512143944, renato.seracchioli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of cancer cells on cryopreserved ovarian tissue (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.