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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who request cryopreservation of ovarian tissue | Other | Patients who request cryopreservation of ovarian tissue |
|
| Patients with already cryopreserved ovarian tissue at the criobank | Other | Patients with already cryopreserved ovarian tissue at the criobank |
|
| Patients who request ovarian tissue reimplantation | Other | Patients who request ovarian tissue reimplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step 1 | Other | Cryopreservation of ovarian tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1 year |
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Inclusion Criteria:
For all groups:
Group 1:
Group 2:
Group 3
Exclusion Criteria:
Group 1 and 3
Group 2 None.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renato Seracchioli, MD | Contact | +390512143944 | renato.seracchioli@aosp.bo.it | |
| Rossella Vicenti | Contact | rossella.vicenti@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Renato Seracchioli, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000601529 | SE 1-step Futurabond M |
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| 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 |
|
| Disease-specific detection rate |
Identify the diagnostic method with the highest detection rate for each pathology analyzed, including histo-immunohistochemical investigations and molecular investigations |
| 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 | through study completion, an average of 1 year |