Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05905289
Collaborator
(none)
27
1
2
13.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: observational study

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 (7th ed., 2010).

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 Design

Study Type:
Observational
Anticipated Enrollment :
27 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Survival and Reproductive Outcomes After Fertility-sparing Surgery and Adjuvant Chemotherapy in Malignant Ovarian Germ Cell Tumors
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
group A

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Clinico-pathological characteristics of MOGCTs. [5 years]

    the clinical presentation and histopathological features of MOGCTs.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
    1. Age : younger than 35 years old at first treatment. 2. Fertility-sparing surgery and adjuvant chemotherapy. 3. Pathological diagnosis of malignant ovarian germ cell tumor.
Exclusion Criteria:
  1. Patients with benign ovarian germ cell tumors e.g. mature teratoma.

  2. Concurrent malignancy.

  3. Severe comorbidities that may affect ovarian reproductive function.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Obstetrics & Gynecology Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Mahmoud Ahmed Abd El Hameed, MD, Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Ahmed Ismail Abd El Hameed, Dr, Cairo University
ClinicalTrials.gov Identifier:
NCT05905289
Other Study ID Numbers:
  • N-181-2023
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mahmoud Ahmed Ismail Abd El Hameed, Dr, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023