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NCT00526032 · ClinicalTrials.gov registry record
Melanoma Detection by Oblique-Incidence Optical Spectroscopy
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 490
- Enrollment target
NCT00526032: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00526032 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 490 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00526032 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 490 participants
- Enrollment target
Study Summary
Primary Objectives: * To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the adjacent normal skin for self-referencing. The experimental database will contain demographic information, clinical diagnoses, clinical images, OIR images, histopathologic diagnoses, and morphometric data on the lesions. * To develop and validate a diagnostic algorithm: 1. Classification: A subset (\~50%) of OIR images collected will be used to complete the development of state-of-the-art image processing algorithms to extract robustly effective diagnostic features. 2. Blind Testing and Evaluation: The algorithms established will be evaluated and validated in a prospective blind-test fashion using the complementary subset of the database that was not involved in designing the classifier. The sensitivity and specificity of the classification system will be evaluated based on the receiver-operating-characteristic (ROC) curve. * To identify the pathophysiologic parameters responsible for the diagnostic optical features: The anatomic and physiologic sources of the diagnostic optical signatures will be identified by comparative analyses using the OIR images, microscopic histomorphometric techniques and theoretical modeling to test the following hypotheses: 1. The calculated differences in hemoglobin oxygen saturation. 2. Comparisons of the calculated size distributions of skin scattering centers with histologic and morphometric analyses of various cellular and tissue components of the skin lesions. 3. The relative densities and distributions of the different anatomic and physiologic diagnostic features within the interrogation volumes are important diagnostic factors in OIR.
Interventions
- PROCEDURE OIR Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00526032
The ClinicalTrials.gov registry entry for NCT00526032 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 490 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 1 intervention - of which OIR Imaging is the first listed.
NCT00526032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00526032 about?
NCT00526032 is a clinical study titled "Melanoma Detection by Oblique-Incidence Optical Spectroscopy". Primary Objectives: * To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routine...
What is the current status of trial NCT00526032?
This trial is currently completed. The enrollment target is 490 participants. The study started on 2006-09. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00526032?
The interventions under investigation include: OIR Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT00526032?
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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