Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors

Fertility Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05905289
• Other study ID #: N-181-2023
• Status: Completed
• Start date: May 1, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• Neoplasms, Germ Cell and Embryonal

Intervention

Other:
• observational study
no intervention as it is an observational study

Locations

Country	Name	City	State
Egypt	Department of Obstetrics & Gynecology	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reproductive outcomes	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	5 years
Secondary	Clinico-pathological characteristics of MOGCTs.	the clinical presentation and histopathological features of MOGCTs.	5 years