Cervical Cancer Detection Using Optical Spectroscopy
1 other identifier
interventional
350
1 country
1
Brief Summary
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 6, 2026
March 1, 2026
21.8 years
May 11, 2009
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of optical signatures of cervical tissue
The primary outcome of this study is the identification of the optical signatures of cervical tissue.
Day of procedure (less than 10 minutes)
Study Arms (1)
Colposcope
EXPERIMENTALPatients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope
Interventions
This device is a bench-top optical spectrometer
Eligibility Criteria
You may qualify if:
- undergoing colposcopy for the diagnosis of cervical cancer
- LEEP for the treatment of cervical cancer in early stages.
- Follow-up Pap smear in surveillance
You may not qualify if:
- Women under the age of 18 (minors) will be excluded from this study.
- patients will be excluded if she has had a recent episode of bleeding or preterm labor.
- Subjects who are not competent to give consent will excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (2)
Chang VT, Cartwright PS, Bean SM, Palmer GM, Bentley RC, Ramanujam N. Quantitative physiology of the precancerous cervix in vivo through optical spectroscopy. Neoplasia. 2009 Apr;11(4):325-32. doi: 10.1593/neo.81386.
PMID: 19308287RESULTAsiedu MN, Agudogo JS, Dotson ME, Skerrett E, Krieger MS, Lam CT, Agyei D, Amewu J, Asah-Opoku K, Huchko M, Schmitt JW, Samba A, Srofenyoh E, Ramanujam N. A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. Sci Rep. 2020 Oct 6;10(1):16570. doi: 10.1038/s41598-020-72219-9.
PMID: 33024146DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nimmi Ramanujam, Ph.D.
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 13, 2009
Study Start
May 1, 2006
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03