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NCT01512810 · ClinicalTrials.gov registry record · Phase 2
Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer
A Phase 2 study, sponsored by Frederick R. Ueland, M.D..
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT01512810: Completed Phase 2 study, sponsored by Frederick R. Ueland, M.D..
NCT01512810 is a Phase 2 study that has completed, run by Frederick R. Ueland, M.D.. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01512810, a Phase 2 study, has completed, sponsored by Frederick R. Ueland, M.D..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.
Primary Outcome
Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).
Interventions
- PROCEDURE Lymphadenectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-01 |
| Est. Completion | 2021-08-26 |
| Phase | Phase 2 |
What the finished NCT01512810 record still lists
NCT01512810 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which Lymphadenectomy is the first listed.
NCT01512810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01512810 about?
NCT01512810 is a clinical study titled "Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer". Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reprodu...
What is the current status of trial NCT01512810?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2012-01. Estimated completion is 2021-08-26.
What interventions are being tested in trial NCT01512810?
The interventions under investigation include: Lymphadenectomy (PROCEDURE).
Who is sponsoring clinical trial NCT01512810?
This trial is sponsored by Frederick R. Ueland, M.D., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01512810's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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