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出境医 / 临床实验 / Ketohexokinase Isoforms in Endometrial Cancer.
Ketohexokinase Isoforms in Endometrial Cancer.
Study Description
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 |
Study Design
| 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 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 25, 2019 | ||||
| First Posted Date | April 30, 2019 | ||||
| Last Update Posted Date | June 2, 2020 | ||||
| Actual Study Start Date | April 11, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Ketohexokinase Isoforms in Endometrial Cancer. | ||||
| Official Title | Prognostic Evaluations of Ketohexokinase Isoforms in Endometrial Cancer | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Women with endometrial cancer who underwent staging surgeries in the Far Eastern Memorial Hospital | ||||
| Condition | Endometrial Cancer | ||||
| Intervention | Diagnostic Test: ketohexokinase
Check the isoforms of ketohexokinase in the specimen of endometrial cancer
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
220 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2024 | ||||
| Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Taiwan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03931265 | ||||
| Other Study ID Numbers | 108009-F | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Sheng-Mou Hsiao, Far Eastern Memorial Hospital | ||||
| Study Sponsor | Far Eastern Memorial Hospital | ||||
| Collaborators | Gynecologic Oncology Group | ||||
| Investigators | Not Provided | ||||
| PRS Account | Far Eastern Memorial Hospital | ||||
| Verification Date | May 2020 | ||||
