Clinical trial NCT05905289: Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors
Official title: Survival and Reproductive Outcomes After Fertility-sparing Surgery and Adjuvant Chemotherapy in Malignant Ovarian Germ Cell Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Issues
Keywords: Ovarian germ cell tumors
Fertility sparing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Malignant ovarian germ cell tumor patients conducted fertility-sparing surgery and adjuvant chemotherapy with complete follow up data from January 2012 to December 2016 will be retrospectively investigated.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age : younger than 35 years old at first treatment.
* Fertility-sparing surgery and adjuvant chemotherapy.
* Pathological diagnosis of malignant ovarian germ cell tumor.

Exclusion Criteria:

* Patients with benign ovarian germ cell tumors e.g. mature teratoma.
* Concurrent malignancy.
* Severe comorbidities that may affect ovarian reproductive function.

Primary outcomes:
measure: reproductive outcomes
timeFrame: 5 years
Secondary outcomes:
measure: Clinico-pathological characteristics of MOGCTs.
timeFrame: 5 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics & Gynecology
Study officials:
affiliation: Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University
name: Mahmoud Ahmed Abd El Hameed, MD
role: PRINCIPAL_INVESTIGATOR
References: