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
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First Received Date ICMJE | July 29, 2011 | ||||
Last Updated Date | September 2, 2012 | ||||
Start Date ICMJE | July 2012 | ||||
Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406769 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of Vulvar Cancer | ||||
Brief Summary | RATIONALE: Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery. PURPOSE: 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. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients undergo preoperative and postoperative lower-extremity lymphedema assessment comprising serial circumferential measurements, bioimpedance spectroscopy measurements, and clinical evaluation using the Stemmer sign. Patients undergo radical vulvectomy or radical local excision as prescribed by GOG-0244, and unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy. After completion of study, patients are followed up at 4-6 weeks, every 3 months for 1 year, and then every 6 months for 1 year. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Diagnostic |
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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 ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 120 | ||||
Completion Date | |||||
Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT01406769 | ||||
Other Study ID Numbers ICMJE | CDR0000706551, GOG-0269 | ||||
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Responsible Party | Philip J. DiSaia, Gynecologic Oncology Group | ||||
Study Sponsor ICMJE | Gynecologic Oncology Group | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |