Cervical Cancer Detection Using Optical Spectroscopy

NCT ID: NCT00900575

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2026-01-31

Brief Summary

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The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Colposcope

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

Group Type EXPERIMENTAL

Optical Spectroscopy Bench-Top System

Intervention Type DEVICE

This device is a bench-top optical spectrometer

Portable Optical Spectrometer

Intervention Type DEVICE

This device is a portable optical spectrometer

Transvaginal colposcope

Intervention Type DEVICE

Interventions

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Optical Spectroscopy Bench-Top System

This device is a bench-top optical spectrometer

Intervention Type DEVICE

Portable Optical Spectrometer

This device is a portable optical spectrometer

Intervention Type DEVICE

Transvaginal colposcope

Intervention Type DEVICE

Other Intervention Names

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TVDC Transvaginal digital colposcope, Pocket colposcope, callascope

Eligibility Criteria

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Inclusion Criteria

* undergoing colposcopy for the diagnosis of cervical cancer
* LEEP for the treatment of cervical cancer in early stages.
* Follow-up Pap smear in surveillance

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nimmi Ramanujam, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nimmi Ramanujam, Ph.D.

Role: CONTACT

919-660-5307

References

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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.

Reference Type RESULT
PMID: 19308287 (View on PubMed)

Asiedu 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.

Reference Type DERIVED
PMID: 33024146 (View on PubMed)

Related Links

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https://www.globalwomenshealthtechnologies.com/

PI website to see ongoing research

Other Identifiers

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Pro00008173

Identifier Type: -

Identifier Source: org_study_id

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