Cervical CancerNCT00900575
Cervical Cancer Detection Using Optical Spectroscopy
A study testing Optical Spectroscopy Bench-Top System, Portable Optical Spectrometer and Transvaginal colposcope in people with Cervical Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Optical Spectroscopy Bench-Top System, Portable Optical Spectrometer and Transvaginal colposcope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing colposcopy for the diagnosis of cervical cancer
- LEEP for the treatment of cervical cancer in early stages.
- Follow-up Pap smear in surveillance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Nimmi Ramanujam, Ph.D.
John Schmitt, M.D.
About this study
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
- Conditions
- Cervical Cancer
- Being tested
- Optical Spectroscopy Bench-Top System, Portable Optical Spectrometer, Transvaginal colposcope
- Keywords
- cervical cancer, LEEP, colposcopy, Pap smear
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Spectroscopy Bench-Top SystemDevice
This device is a bench-top optical spectrometer
Portable Optical SpectrometerDevice
This device is a portable optical spectrometer
Transvaginal colposcopeDevice
Also called TVDC, Transvaginal digital colposcope, Pocket colposcope, callascope
| Study group | Role | What they receive |
|---|---|---|
| Colposcope | Experimental | Patients 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 Receives: Device: Optical Spectroscopy Bench-Top System; Device: Portable Optical Spectrometer; Device: Transvaginal colposcope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of optical signatures of cervical tissue
The primary outcome of this study is the identification of the optical signatures of cervical tissue.
Measured: Day of procedure (less than 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2006
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimmi Ramanujam, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900575
- Sponsor's protocol ID
- Pro00008173
- Status last verified
- Mar 2026
- First submitted
- 11 May 2009
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19308287Asiedu 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.
PubMed 33024146
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Detection Using Optical Spectroscopy
- ClinicalTrials.gov ID
- NCT00900575
- Acronym / sponsor ID
- Pro00008173
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, LEEP, colposcopy, Pap smear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2006 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colposcope | Experimental | Device: Optical Spectroscopy Bench-Top System, Device: Portable Optical Spectrometer, Device: Transvaginal colposcopePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing colposcopy for the diagnosis of cervical cancer
- LEEP for the treatment of cervical cancer in early stages.
- Follow-up Pap smear in surveillance
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Spectroscopy Bench-Top SystemThis device is a bench-top optical spectrometer | Device | Colposcope |
| Portable Optical SpectrometerThis device is a portable optical spectrometer | Device | Colposcope |
| Transvaginal colposcopeAlso: TVDC, Transvaginal digital colposcope, Pocket colposcope, callascope | Device | Colposcope |
Primary outcome
Identification of optical signatures of cervical tissue
Time frame: Day of procedure (less than 10 minutes)
The primary outcome of this study is the identification of the optical signatures of cervical tissue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 19308287Chang 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.
- Derived from this study: PubMed 33024146Asiedu 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.
- PI website to see ongoing researchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nimmi Ramanujam, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Spectroscopy Bench-Top System, Portable Optical Spectrometer and Transvaginal colposcope in people with Cervical Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nimmi Ramanujam, Ph.D. (919-660-5307, nimmi@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of optical signatures of cervical tissue (time frame: Day of procedure (less than 10 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.