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Low-Cost Imaging for Cervical Cancer

Phase < 1
Waitlist Available
Led By Ana M Rodriguez, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with an abnormal Pap test, positive HPV test, or any history of cervical dysplasia
Women of childbearing potential must have a negative urine or serum pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial is testing a new type of medical equipment to see if it's as effective as the current equipment in diagnosing cervical pre-cancerous lesions and cancer. If it is, it could mean that patients wouldn't have to wait for biopsy results before getting treatment.

Who is the study for?
This trial is for women over 21 with an intact cervix who have had abnormal Pap tests, positive HPV tests, or a history of cervical dysplasia. It includes those who've had treatments like LEEP, cone, or cryotherapy. Pregnant or nursing women and those allergic to proflavine or iodine can't join.Check my eligibility
What is being tested?
The study is testing the High-Resolution Microendoscope (HRME) against current clinical equipment for diagnosing cervical pre-cancer and cancer. The goal is to see if HRME can provide immediate diagnosis without waiting for biopsy results.See study design
What are the potential side effects?
There may be minimal side effects related to the use of Proflavine during imaging such as mild irritation. However, specific side effects are not detailed in this summary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had an abnormal Pap test, a positive HPV test, or a history of cervical dysplasia.
Select...
I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)

Trial Design

1Treatment groups
Experimental Treatment
Group I: High-Resolution Microendoscopy (HRME)Experimental Treatment2 Interventions
After standard colposcopy examination performed, participants undergo a high-resolution microendoscopy imaging procedure. Proflavine 0.01% is applied to the cervix, then high-resolution microendoscopy imaging procedure performed. Standard colposcopy procedure will then continue.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proflavine
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,448 Total Patients Enrolled
William Marsh Rice UniversityOTHER
45 Previous Clinical Trials
27,703 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,968 Previous Clinical Trials
1,786,722 Total Patients Enrolled

Media Library

High-Resolution Microendoscopy (HRME) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02714439 — Phase < 1
Cervical Cancer Research Study Groups: High-Resolution Microendoscopy (HRME)
Cervical Cancer Clinical Trial 2023: High-Resolution Microendoscopy (HRME) Highlights & Side Effects. Trial Name: NCT02714439 — Phase < 1
High-Resolution Microendoscopy (HRME) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02714439 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this clinical research?

"At this time, the trial is not currently accepting participants. It was initially posted on October 25th 2016 and last modified on August 16th 2022. If you are looking for other studies with similar topics, there are presently 2698 trials recruiting participants who have uterine cervical neoplasms and 3 clinical tests related to Proflavine that are actively enrolling patients."

Answered by AI

Have there been any other investigations involving Proflavine?

"At present, there are 3 studies for Proflavine in operation with none of them reaching Phase 3. All the experiments are based mostly out of Houston and have a few satellite locations running trials too."

Answered by AI

Does this study include participants from the younger demographic?

"Applicants that wish to partake in this investigation must be aged between 21 and 65. For those not eligible, there are 312 trials available for minors and 2484 studies open to elderly applicants."

Answered by AI

Is it possible to register for participation in this trial?

"This clinical trial is seeking 150 individuals aged 21-65, who have been diagnosed with uterine cervical neoplasm. To be eligible for the project, participants must still possess an intact cervix and are available to receive excisional procedures like LEEP or cryotherapy if clinically indicated. Furthermore, medical imaging studies may be conducted as well as additional biopsies taken at no cost to the patient but exclusively for research purposes."

Answered by AI

Are there any available opportunities to join this experiment?

"This research project is no longer taking in patients. It was first posted on October 25th 2016 and the last update to this trial occurred on August 16th 2022. If you are searching for other clinical trials, there are currently 2698 trials recruiting individuals with uterine cervical neoplasms and 3 studies actively accepting participants for Proflavine treatment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas Medical Branch Cancer Stop McAllen Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
2016. "Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02714439.
All > Cervical Cancer > Genital Warts
~20 spots leftby Jul 2025
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