Clinical trial · Observational
Spectroscopic Evaluation of Cervical Neoplasia
Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix. The specific aims of the study are: * To compare information obtained from fluorescence and reflectance spectroscopic measurements of the cervix with standard methods for detecting cervical pre-cancers. * To validate previously developed algorithms for discriminating between normal and pre-cancerous tissue based on spectroscopic measurements. * To evaluate the safety of spectroscopic measurement of cervical tissue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Procedure: Spectroscopy and Digital Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the efficacy of the CNDS, within the context of current ASCCP guidelines, to more effectively triage women with ASC/LSIL results, women with positive HPV results and women being followed for previous cervical dysplasia.
- timeFrame
- December 2008
Secondary outcomes (1)
- measure
- A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial.
- timeFrame
- Q1 2009
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Age 16 or above * Able to read or understand and give informed consent * Scheduled for colposcopy * Pap test within 120 days * Willing to undergo a Pap test and HPV test on day of study Exclusion Criteria: * Pregnancy * Menstruating on the day of colposcopy and CNDS test * Radiation therapy to her genitourinary system within 1 year * Prior hysterectomy * Congenital anatomical cervical variant (e.g., double cervix) * Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma) * Post-coital or other significant bleeding at the time of the exam * Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy, resulting from inflammatory, bacterial or other sources * History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus). * Undergoing phototherapy * Recent use of photosensitizing agents, such as fluoroquinolones or retinoids). * Patients who are pregnant are not eligible for this study.
References
Publications (0)
Data not yet available