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Optical Spectroscopy for Cervical Cancer Detection

N/A

Recruiting

Led By Nimmi Ramanujam, Ph.D.

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing LEEP for the treatment of cervical cancer in early stages

Patients undergoing colposcopy for the diagnosis of cervical cancer

Must not have

Women under the age of 18 (minors)

Subjects who are not competent to give consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of procedure (less than 10 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial will use optical technologies to look for signs of cervical dysplasia.

Who is the study for?

This trial is for women undergoing colposcopy, LEEP procedures, or follow-up Pap smears for cervical cancer diagnosis and treatment. It's not open to those under 18, anyone unable to consent, or patients with recent bleeding or preterm labor.

What is being tested?

The study is testing optical technologies like a bench-top system, portable spectrometer, and transvaginal colposcope to identify the unique optical patterns of precancerous changes in the cervix.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort from the use of the devices during examination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving LEEP for early-stage cervical cancer.

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I am having a colposcopy to check for cervical cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman under 18 years old.

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I am unable to understand and give consent for my own treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of procedure (less than 10 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of procedure (less than 10 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of procedure (less than 10 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identification of optical signatures of cervical tissue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ColposcopeExperimental Treatment3 Interventions

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

0 / 4Eligibility criteria met