Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Detection rate of cancer cells on cryopreserved ovarian tissue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
- •Age >18 years
- •Ovarian tissue already collected and cryopreserved at the Laboratory for Cryopreservation of Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO
- •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
排除标准
- •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.
研究组 & 干预措施
Patients who request ovarian tissue reimplantation
Patients who request ovarian tissue reimplantation
干预措施: Step 4 (Other)
Patients who request cryopreservation of ovarian tissue
Patients who request cryopreservation of ovarian tissue
干预措施: Step 1 (Other)
Patients who request cryopreservation of ovarian tissue
Patients who request cryopreservation of ovarian tissue
干预措施: Step 2 (Other)
Patients who request cryopreservation of ovarian tissue
Patients who request cryopreservation of ovarian tissue
干预措施: Step 3 (Other)
Patients with already cryopreserved ovarian tissue at the criobank
Patients with already cryopreserved ovarian tissue at the criobank
干预措施: Step 2 (Other)
Patients with already cryopreserved ovarian tissue at the criobank
Patients with already cryopreserved ovarian tissue at the criobank
干预措施: Step 3 (Other)
Patients who request ovarian tissue reimplantation
Patients who request ovarian tissue reimplantation
干预措施: Step 2 (Other)
Patients who request ovarian tissue reimplantation
Patients who request ovarian tissue reimplantation
干预措施: Step 3 (Other)
结局指标
主要结局
Detection rate of cancer cells on cryopreserved ovarian tissue
时间窗: 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)
次要结局
- Concordance of histological/molecular investigations(through study completion, an average of 1 year)
- Disease-specific detection rate(through study completion, an average of 1 year)
- Ovarian contamination(through study completion, an average of 1 year)
