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NCT01406769 · ClinicalTrials.gov registry record · Phase 2
Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy
A Phase 2 study, sponsored by Gynecologic Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01406769: Completed Phase 2 study, sponsored by Gynecologic Oncology Group.
NCT01406769 is a Phase 2 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01406769, a Phase 2 study, has completed, sponsored by Gynecologic Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity lymphedema in patients with stage I, stage II, stage III, or stage IV vulvar cancer undergoing surgery and lymphadenectomy. Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery.
Primary Outcome
The usual assessment of sensitivity and specificity using the volume based diagnosis as the ?Gold Standard? after an receiver operating characteristic (ROC) analysis to determine the cut-point for the definition of a diagnosis of lymphedema by the bioimpedance method will be performed.
Interventions
- PROCEDURE Therapeutic Conventional Surgery
- PROCEDURE Lymphadenectomy
- PROCEDURE Bioelectric Impedance Analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-07-16 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 2 |
What the finished NCT01406769 record still lists
NCT01406769 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Therapeutic Conventional Surgery is the first listed.
NCT01406769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01406769 about?
NCT01406769 is a clinical study titled "Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy". This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity lymphedema in patients with stage I, stage II, stage III, or stage IV vulvar cancer undergoing surgery and lymphadenectomy. Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the ons...
What is the current status of trial NCT01406769?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2012-07-16. Estimated completion is 2020-04-10.
What interventions are being tested in trial NCT01406769?
The interventions under investigation include: Therapeutic Conventional Surgery (PROCEDURE), Lymphadenectomy (PROCEDURE), Bioelectric Impedance Analysis (PROCEDURE).
Who is sponsoring clinical trial NCT01406769?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01406769's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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