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Active, Not Recruiting

NCT Number: NCT01820884

The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • FIGO stage: ⅠA, endometrial carcinoma;
  • Female, Chinese women;
  • premenopausal women；
  • ≤ 50 years old;
  • Pathological diagnosis by curettage/hysteroscopy : G1
  • No prior treatment;
  • Provide written informed consent.

Exclusion criteria

  • The suspicious metastasis of ovarian;
  • Family history of ovarian cancer;
  • Suffering from other malignancies;
  • Concurrently participating in other clinical trials;
  • Unable or unwilling to sign informed consents;
  • Unable or unwilling to abide by protocol.

Treatment and study plan

TH

Procedure

Total hysterectomy

TH/BSO

Procedure

Total hysterectomy and bilateral salpingo-oophorectomy

BPLND

Procedure

bilateral pelvic and para-aortic lymph node dissection

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 3-year DFS

Secondary outcomes

  1. Clinical gynecologic endocrine function

    Time frame: 1-year period

    To observe the level of female hormone，i.e., estrogen, FSH, LH

  2. Quality of Life

    Time frame: 3-year period

  3. Overall Survival (OS)

    Time frame: 3-year OS

Sponsors and collaborators

Lead sponsor

Ding Ma

Other

Collaborators

  • Huazhong University of Science and Technology
  • Shandong University
  • Zhejiang University

Registry information

Official study title

The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial

Acronym: EC-02

Important dates

Study start
2012
Primary completion
2025
Study completion
2026
First posted
Mar 29, 2013
Registry last updated
Apr 2, 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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