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NCT Number: NCT05905289

Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics & Gynecology

Cairo, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational study

Other

no intervention as it is an observational study

Primary outcomes

  1. 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

  1. Clinico-pathological characteristics of MOGCTs.

    Time frame: 5 years

    the clinical presentation and histopathological features of MOGCTs.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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