IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
Location contact
Renato Seracchioli, MD
CONTACT
Renato Seracchioli, MD
PRINCIPAL_INVESTIGATOR
Rossella Vicenti
CONTACT
NCT Number: NCT06829654
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.
Interested in participating?
Request Info18 year–38 year
Female
Interventional
Not applicable
Bologna, 40138, Italy
Location status: Recruiting
Renato Seracchioli, MD
CONTACT
Renato Seracchioli, MD
PRINCIPAL_INVESTIGATOR
Rossella Vicenti
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all groups:
Group 1:
Group 2:
Group 3
Exclusion criteria
Group 1 and 3
Group 2 None.
Cryopreservation of ovarian tissue
Analysis of tumor markers in the primary tumor
Search for neoplastic cells in cryopreserved ovarian tissue
Cryopreserved ovarian tissue autotransplantation
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)
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
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
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
Contact information is provided by the study sponsor or research team.
Renato Seracchioli, MD
CONTACT
Rossella Vicenti
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors
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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