Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors

Completed

• Conditions: Fertility Issues
• Interventions: Other: observational study

• Registration Number: NCT05905289
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group A	observational study	young female patients diagnosed with malignant ovarian germ cell tumors underwent fertility-sparing surgery and adjuvant chemotherapy will be retrospectively investigated

Primary Outcome Measures

Name	Time	Method
reproductive outcomes	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

Secondary Outcome Measures

Name	Time	Method
Clinico-pathological characteristics of MOGCTs.	5 years	the clinical presentation and histopathological features of MOGCTs.

Trial Locations

Locations (1)

Department of Obstetrics & Gynecology; 🇪🇬 Cairo, Egypt