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临床试验/NCT06829654
NCT06829654招募中不适用

Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月12日最近更新:
适应症
干预措施

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

Other

Patients who request ovarian tissue reimplantation

干预措施: Step 4 (Other)

Patients who request cryopreservation of ovarian tissue

Other

Patients who request cryopreservation of ovarian tissue

干预措施: Step 1 (Other)

Patients who request cryopreservation of ovarian tissue

Other

Patients who request cryopreservation of ovarian tissue

干预措施: Step 2 (Other)

Patients who request cryopreservation of ovarian tissue

Other

Patients who request cryopreservation of ovarian tissue

干预措施: Step 3 (Other)

Patients with already cryopreserved ovarian tissue at the criobank

Other

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

Other

Patients with already cryopreserved ovarian tissue at the criobank

干预措施: Step 3 (Other)

Patients who request ovarian tissue reimplantation

Other

Patients who request ovarian tissue reimplantation

干预措施: Step 2 (Other)

Patients who request ovarian tissue reimplantation

Other

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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