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NCT Number: NCT04227249

3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer

To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection

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Key information

Conditions

Endometrial Cancer 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

19 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

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

Inclusion criteria

  • endometrioid type
  • anticipated surgery omitting lymph node dissection for endometrial cancer
  • pelvis MRI, CA125 - satisfying KGOG criteria
  • no distant metastasis
  • age 19 or more

Exclusion criteria

  • other cancer within 5 yr
  • previous hysterectomy
  • previous therapy for endometrial cancer

Treatment and study plan

no lymph node dissection

Procedure

do not undergo lymph node dissection

Primary outcomes

  1. 3 year recurrence free survival

    Time frame: 3 year since surgery

    3 year recurrence free survival

Secondary outcomes

  1. 5 year recurrence free survival

    Time frame: 5 year since surgery

    5 year recurrence free survival

  2. 5 year overall survival

    Time frame: 5 year since surgery

    5 year overall survival

  3. surgery time

    Time frame: surgery visit

    from surgery start to end

  4. change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline

    Time frame: baseline - 1week - 5week - 3month - 6month

    functional assessment of cancer therapy - general

  5. change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline

    Time frame: baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month

    gynecologic cancer lymphedema questionnaire - Korean

  6. change of Female Sexual Function Index (FSFI) score from baseline

    Time frame: baseline - 6month - 12month - 24month - 36month - 48month - 60month

    female sexual function index

  7. length of stay

    Time frame: surgery visit

    from admission to discharge

  8. transfusion

    Time frame: surgery visit

    amount of transfusion

  9. hemoglobin decline

    Time frame: surgery visit

    change of hemoglobin level from baseline to postoperative lowest level

  10. surgery complication

    Time frame: surgery visit

    any surgery complications observed

Study contacts

Contact information is provided by the study sponsor or research team.

kidong kim, md

CONTACT

[email protected]

82 31 787 7262

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction

Acronym: TREE PRO

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Jan 13, 2020
Registry last updated
Jan 14, 2020

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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