Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors

NCT ID: NCT05905289

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-11

Brief Summary

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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

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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.

Conditions

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Fertility Issues

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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group A

young female patients diagnosed with malignant ovarian germ cell tumors underwent fertility-sparing surgery and adjuvant chemotherapy will be retrospectively investigated

observational study

Intervention Type OTHER

no intervention as it is an observational study

Interventions

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observational study

no intervention as it is an observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Ahmed Ismail Abd El Hameed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Ahmed Abd El Hameed, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University

Locations

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Department of Obstetrics & Gynecology

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-181-2023

Identifier Type: -

Identifier Source: org_study_id

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