Survival and Reproductive Outcomes After Fertility-sparing Surgery and Adjuvant Chemotherapy in Malignant Ovarian Germ Cell Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- reproductive outcomes
研究概览
简要总结
Malignant ovarian germ cell tumor patients conducted fertility-sparing surgery and adjuvant chemotherapy in Kasr El-Aini Hospital - Faculty of Medicine - Cairo University from January 2012 to December 2016 will be retrospectively investigated.
详细描述
MOGCT patients conducted fertility-sparing surgery and adjuvant chemotherapy with complete follow up data, younger than 35 years old at first treatment, in Kasr El-Aini Hospital - Faculty of Medicine - Cairo University ( Department of Obstetrics & Gynecology and Center of Clinical Oncology and Nuclear Medicine ) from January 2012 to December 2016 will be retrospectively investigated.
Diagnosis of MOGCT was revealed by pelvic mass, abdominal pain, and elevated tumor markers like α-fetoprotein (AFP), human choionic gonadotophin (HCG) and lactate dehydrogenase (LDH) and confirmed by surgical procedure and pathological diagnosis. Pathological diagnosis was confirmed according to the 2014 World Health Organization classification of tumors of female reproductive organs. Tumors were staged according to American Joint Committee of Cancer (AJCC), TNM and FIGO staging system for Ovarian and Primary Peritoneal Cancer.
Fertility sparing surgery preserves uterus and the contralateral ovary with or without comprehensive staging (omentectomy and lymphadenectomy) by open laparotomy. Adjuvant chemotherapy was scheduled based on histopathology, grade and stage. All patients received chemotherapy, but with different schemes and courses The data including: subjects' demographics, clinical and pathological characteristics, treatment received, survival outcome and reproductive outcomes including pregnancy rate ( natural conception ) and live birth rate will be investigated. Follow-up data until January 31, 2022 will be collected from hospital records and telephone interview.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age : younger than 35 years old at first treatment.
- •Fertility-sparing surgery and adjuvant chemotherapy.
- •Pathological diagnosis of malignant ovarian germ cell tumor.
排除标准
- •Patients with benign ovarian germ cell tumors e.g. mature teratoma.
- •Concurrent malignancy.
- •Severe comorbidities that may affect ovarian reproductive function.
结局指标
主要结局
reproductive outcomes
时间窗: 5 years
To report and analyze reproductive outcome including pregnancy rate and live birth rate after fertility-sparing surgery and adjuvant chemotherapy in malignant ovarian germ cell tumors
次要结局
- Clinico-pathological characteristics of MOGCTs.(5 years)
研究者
Mahmoud Ahmed Ismail Abd El Hameed
Principal Investigator
Cairo University
