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NCT00529464 · ClinicalTrials.gov registry record · Phase 3
Spectroscopy Versus Standard Care in Cervical Cancer Patients
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT00529464: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00529464 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00529464, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study Summary
Primary objectives 1. To conduct a randomized clinical trial of the emerging technology fluorescence and reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively. The number of clinically read referral Paps, clinically read UT MD Anderson Cancer Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point probe fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy image, that shows a possible cancer, High-grade Squamous Intraepithelial Lesion (HGSIL), Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL to colposcopically directed biopsies at the first visit, Loop Electrical Excision Procedure (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18 months that have Paps, or Paps + Endocervical Curettage or sample of the cervical canal + possible biopsy, and at the 24 month visit when all patients will at minimum have a Pap and an Endocervical Curettage for certain, and a cervical biopsy if any colposcopic abnormality is present. 2. To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone. 1. To study the number of colposcopically directed biopsies that show High-grade Squamous Intraepithelial or cancer. 2. To study the number of LEEP specimens that show HGSIL or cancer.
Interventions
- PROCEDURE Colposcopy
- PROCEDURE Fluorescence Spectroscopy
- PROCEDURE LEEP Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00529464
The ClinicalTrials.gov registry entry for NCT00529464 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Colposcopy is the first listed.
NCT00529464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00529464 about?
NCT00529464 is a clinical study titled "Spectroscopy Versus Standard Care in Cervical Cancer Patients". Primary objectives 1. To conduct a randomized clinical trial of the emerging technology fluorescence and reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low grade and high grade squamo...
What is the current status of trial NCT00529464?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2006-11. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00529464?
The interventions under investigation include: Colposcopy (PROCEDURE), Fluorescence Spectroscopy (PROCEDURE), LEEP Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT00529464?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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