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NCT01526486 · ClinicalTrials.gov registry record · NA
Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer
A NA study of Melanoma and Squamous Cell Carcinoma, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01526486: Completed NA study of Melanoma and Squamous Cell Carcinoma, sponsored by Emory University.
NCT01526486 is a NA study of Melanoma and Squamous Cell Carcinoma that has completed, run by Emory University. The registered enrollment target is 29 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526486, a NA study of Melanoma and Squamous Cell Carcinoma, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with melanoma, some other rare skin cancers, and some cancers of the penis and scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called the groin. Medically, this area is called the inguinal area. At present, for melanomas and skin cancers this type of spread is usually found with a special test called a "sentinel lymph node biopsy". This procedure can find spread of even a few cells in a single lymph node-allowing the treating doctor to find the spread very early. Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot have any evidence of cancer having spread either by physical examination or by radiology tests, the lymph nodes in this area are removed to check and see if there is cancer in them. This is called staging. At present, the standard way to remove all of the lymph nodes in the groin is by a large incision, approximately 8-10 inches in length. For patients who have this operation, there is a very high incidence of infection after surgery: as many as 50% as patients can have a problem after surgery. These infections range from a low grade skin infection needing oral antibiotics to deep infections requiring the wound to be opened and occasionally needing readmission to the hospital and antibiotics given via the vein. With the advent of new technology and new equipment, the ability to perform this procedure through small incisions away from the groin and further down the leg has become possible. This procedure has never been performed routinely nor compared side by side to the standard open approach. The investigators propose to perform this protocol in two phases. The investigators have performed procedures in 20 groins to this point and have confirmed the number of lymph nodes and visually verified that the procedure is identical to the open procedure. The investigators performed th
Primary Outcome
The primary objective is to assess wound infection, wound dehiscence and other wound complications.
Conditions Studied
Interventions
- PROCEDURE Videoscopic procedure
- PROCEDURE Open, traditional approach
Study Locations (1)
Georgia
- Emory University Hospital-Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01526486 record still lists
NCT01526486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).
The record links to 10 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Videoscopic procedure is the first listed.
NCT01526486 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01526486 about?
NCT01526486 is a clinical study titled "Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer". Patients with melanoma, some other rare skin cancers, and some cancers of the penis and scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called the groin. Medically, this area is called the inguinal area. At present, for melanomas and skin cancers this type of sp...
What is the current status of trial NCT01526486?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2009-06. Estimated completion is 2013-02.
What conditions does trial NCT01526486 study?
This clinical trial studies the following conditions: Melanoma, Squamous Cell Carcinoma, Skin Cancer, Merkel Cell Carcinoma, Anal Cancer.
What interventions are being tested in trial NCT01526486?
The interventions under investigation include: Videoscopic procedure (PROCEDURE), Open, traditional approach (PROCEDURE).
Who is sponsoring clinical trial NCT01526486?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01526486 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01526486's enrollment target sits among peer trials
29 205th of 266 higher than 61 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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