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Clinical Trials/NCT05905289
NCT05905289
Completed
N/A

Survival and Reproductive Outcomes After Fertility-sparing Surgery and Adjuvant Chemotherapy in Malignant Ovarian Germ Cell Tumors

Cairo University1 site in 1 country27 target enrollmentMay 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fertility Issues
Sponsor
Cairo University
Enrollment
27
Locations
1
Primary Endpoint
reproductive outcomes
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
December 11, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Ahmed Ismail Abd El Hameed

Principal Investigator

Cairo University

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.

Outcomes

Primary Outcomes

reproductive outcomes

Time Frame: 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 Outcomes

  • Clinico-pathological characteristics of MOGCTs.(5 years)

Study Sites (1)

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