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Ketohexokinase Isoforms in Endometrial Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931265
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Brief Summary:
Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. To understand the importance of ketohexokinase expression and isoform switch during the development of type I endometrial cancer, we propose a series of in vitro experiments and clinical examinations in this project.

Condition or disease Intervention/treatment
Endometrial Cancer Diagnostic Test: ketohexokinase

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 220 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prognostic Evaluations of Ketohexokinase Isoforms in Endometrial Cancer
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Intervention Details:
  • Diagnostic Test: ketohexokinase
    Check the isoforms of ketohexokinase in the specimen of endometrial cancer


Primary Outcome Measures :
  1. The role of ketohexokinase isoforms in the overall survival of endometrial cancer. [ Time Frame: 5 years ]
    Cox proportional hazard regression to evaluate the role of ketohexokinase isoforms in the overall survival of endometrial cancer.


Secondary Outcome Measures :
  1. Correlation of ketohexokinase isoforms with the other prognostic risk factors [ Time Frame: 5 years ]
    Correlation of ketohexokinase isoforms with deep myometrial invasion, tumor grade, lymph node metastasis, FIGO stage, tumor size, progression-free survival, etc.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with endometrial cancer who underwent staging surgeries in the Far Eastern Memorial Hospital
Criteria

Inclusion Criteria:

  • >20 years
  • Women with endometrial cancer who are about to be admitted to hospital for gynecological staging.
  • Women who have undergone gynecological staging surgery for endometrial cancer in the past.

Exclusion Criteria:

  • Women with endometrial cancer who receive preoperative chemotherapy or radiation therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931265


Contacts
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Contact: Sheng-Mou Hsiao, MD +886289667000 ext 1818 smhsiao2@gmail.com

Locations
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Taiwan
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital Recruiting
Banqiao, New Taipei, Taiwan, 22050
Contact: Sheng-Mou Hsiao, M.D.    +886-2-89667000 ext 1818    smhsiao2@gmail.com   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Gynecologic Oncology Group
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Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT03931265    
Other Study ID Numbers: 108009-F
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female