Trial Outcomes & Findings for Spectroscopy Versus Standard Care in Cervical Cancer Patients (NCT NCT00529464)
NCT ID: NCT00529464
Last Updated: 2016-05-09
Results Overview
A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.
TERMINATED
PHASE3
2 participants
Up to 2 years
2016-05-09
Participant Flow
Recruitment Period: 11/08/06 through 05/01/08. All participants recruited at UT MD Anderson Cancer Center.
Two patients were recruited, both ineligible, with no research related procedures performed. Study terminated early due to low enrollment.
Participant milestones
| Measure |
Colposcopy
Colposcopy - a direct magnified inspection of cervix.
|
Colposcopy + Fluorescence Spectroscopy
Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
|
Colposcopy + LEEP
Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spectroscopy Versus Standard Care in Cervical Cancer Patients
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: The primary outcome measure could not be assessed because no subject received randomized treatment assignment. The study was terminated.
A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.
Outcome measures
Outcome data not reported
Adverse Events
Colposcopy
Colposcopy + Fluorescence Spectroscopy
Colposcopy + LEEP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Helen E. Rhodes, MD / Assistant Professor
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place