Malignant Neoplasms of Female Genital OrgansEarly Phase 1NCT02714439
Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
A Early Phase 1 study testing Proflavine and High-Resolution Microendoscopy (HRME) in people with Malignant Neoplasms of Female Genital Organs, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions and cervical cancer. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Malignant Neoplasms of Female Genital Organs
- What is being tested?
- Proflavine and High-Resolution Microendoscopy (HRME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2016to 9 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with an abnormal Pap test, positive HPV test or any history of cervical dysplasia
- Women with an intact cervix (patients who have undergone previous LEEP, cone and/or cryotherapy are eligible)
- Women of childbearing potential must have a negative urine or serum pregnancy test
- Women who are at least 21 years of age or older
- Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)
- For patients that present to clinic to have a cervical excisional procedure (LEEP) for an already confirmed diagnosis of high grade cervical dysplasia, HRME imaging study will be performed and cervical biopsies might be taken for research purposes only. Since these patients have already the confirmed diagnosis of high-grade cervical dysplasia, any extra biopsies taken will be for research purposes only and our research fund will pay them
Who cannot join
- Women < 21 years of age
- Women who have undergone a hysterectomy with removal of the cervix
- Women with a known allergy to proflavine, acriflavine, or iodine
- Women who are pregnant or nursing
- Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch Cancer Stop McAllen Clinic
McAllen, Texas, 78501
About this study
The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions and cervical cancer. The investigators want to compare patients' clinical findings using the current equipment used in clinic with the clinical findings using new equipment we are testing on this research project. If the new equipment is proven to give comparable findings with current equipment being used, doctors might be able to offer a diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to come back before women would receive the indicated treatment. Study subjects are being asked to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to have a colposcopic examination to determine the reason for abnormal results and receive treatment.
Read the detailed description
Investigators will start the participants' examination with colposcopic evaluation using current equipment as determined by standard of care. But, if cervical biopsies are indicated, before performing biopsies, for research purposes only - investigators will:
- Apply a substance called Proflavine 0.01% to participants' cervix
- Investigators will re-evaluate participants' cervix with the new equipment being tested:The High- Resolution Microendoscope
- After completing this re-evaluation, investigators will continue with the standard of care protocol and will perform participants' cervical biopsies if indicated.
The entire re-evaluation with the new equipment should add less than 10 minutes to the standard examination.
When a woman is found to have an abnormal PAP smear, depending on the findings and clinical history, most women will need to be further evaluated with a colposcope in order to understand the reason for the abnormal PAP and determine the best treatment. This is called colposcopic examination and it is the standard of care. This procedure is performed in the clinic, patient is positioned on the examining table the same way she is positioned for a Papanicolaou (Pap) smear, a speculum is placed inside the vaginal canal, and certain substances are applied to the cervix in order to identify cervical lesions. These substances might include acetic acid and/or Lugol's iodine solution. The application of these substances helps to delineate the abnormal cervical areas that might need to be biopsied. For the purpose of this research study, before obtaining the biopsies, a second evaluation will be performed using the equipment that is being studied (High- Resolution Microendoscope) and using a different substance that will be applied to the cervix. This substance is called Proflavine 0.01%. . This second evaluation should not take more than 10 minutes. After completing this second evaluation, participants' clinical examination and clinical visit should continue as routine.
The anticipated total number of subjects involved in the study will be 150 women. All these anticipated participating women would be from The University of Texas Medical Branch (UTMB), Su Clinica and UT Health Science Center (UT-HSC) Mobile Van. The length of time for participation is 1 year. However, during the participants' year of enrollment she might have only one examination, during one of her visits,using the research equipment.
- Being tested
- Proflavine, High-Resolution Microendoscopy (HRME)
- Keywords
- Malignant neoplasms of female genital organs, Cervical Cancer Prevention, Abnormal Pap test, Positive HPV test, History of cervical dysplasia, Colposcopy, Proflavine, Proflavine hemisulfate, High-Resolution Microendoscopy, HRME, Human papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProflavineDrug
Also called Proflavine hemisulfate
Proflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed.
High-Resolution Microendoscopy (HRME)Procedure or surgery
High-resolution microendoscopy imaging procedure performed after colposcopy exam. Standard colposcopy procedure will then continue. Entire HRME imaging procedure should add less than 10 minutes to the standard colposcopy exam.
| Study group | Role | What they receive |
|---|---|---|
| High-Resolution Microendoscopy (HRME) | Experimental | 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. Receives: Drug: Proflavine; Procedure: High-Resolution Microendoscopy (HRME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)
Successful outcome defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start25 Oct 2016
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Why it stopped: PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Female Genital OrgansStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, William Marsh Rice University
- Responsible party
- Sponsor
- Investigators
- Ana M Rodriguez, MD, Principal investigator, University of Texas Medical Branch (UTMB)Kathleen Schmeler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714439
- Sponsor's protocol ID
- 0014-0302
- Other IDs
- NCI-2016-00729
- Status last verified
- Jan 2025
- First submitted
- 16 Mar 2016
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
- ClinicalTrials.gov ID
- NCT02714439
- Acronym / sponsor ID
- 0014-0302
- Keywords
- Malignant neoplasms of female genital organs, Cervical Cancer Prevention, Abnormal Pap test, Positive HPV test, History of cervical dysplasia, Colposcopy, Proflavine, Proflavine hemisulfate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left the institution
- Enrolment
- 157 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, William Marsh Rice University
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 21 Mar 2016 (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 purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions and cervical cancer. The investigators want to compare patients' clinical findings using the current equipment used in clinic with the clinical findings using new equipment we are testing on this research project. If the new equipment is proven to give comparable findings with current equipment being used, doctors might be able to offer a diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to come back before women would receive the indicated treatment. Study subjects are being asked to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to have a colposcopic examination to determine the reason for abnormal results and receive treatment.
Detailed description
Investigators will start the participants' examination with colposcopic evaluation using current equipment as determined by standard of care. But, if cervical biopsies are indicated, before performing biopsies, for research purposes only - investigators will:
- Apply a substance called Proflavine 0.01% to participants' cervix
- Investigators will re-evaluate participants' cervix with the new equipment being tested:The High- Resolution Microendoscope
- After completing this re-evaluation, investigators will continue with the standard of care protocol and will perform participants' cervical biopsies if indicated.
The entire re-evaluation with the new equipment should add less than 10 minutes to the standard examination.
When a woman is found to have an abnormal PAP smear, depending on the findings and clinical history, most women will need to be further evaluated with a colposcope in order to understand the reason for the abnormal PAP and determine the best treatment. This is called colposcopic examination and it is the standard of care. This procedure is performed in the clinic, patient is positioned on the examining table the same way she is positioned for a Papanicolaou (Pap) smear, a speculum is placed inside the vaginal canal, and certain substances are applied to the cervix in order to identify cervical lesions. These substances might include acetic acid and/or Lugol's iodine solution. The application of these substances helps to delineate the abnormal cervical areas that might need to be biopsied. For the purpose of this research study, before obtaining the biopsies, a second evaluation will be performed using the equipment that is being studied (High- Resolution Microendoscope) and using a different substance that will be applied to the cervix. This substance is called Proflavine 0.01%. . This second evaluation should not take more than 10 minutes. After completing this second evaluation, participants' clinical examination and clinical visit should continue as routine.
The anticipated total number of subjects involved in the study will be 150 women. All these anticipated participating women would be from The University of Texas Medical Branch (UTMB), Su Clinica and UT Health Science Center (UT-HSC) Mobile Van. The length of time for participation is 1 year. However, during the participants' year of enrollment she might have only one examination, during one of her visits,using the research equipment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Resolution Microendoscopy (HRME) | Experimental | Drug: Proflavine, Procedure: High-Resolution Microendoscopy (HRME)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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women with an abnormal Pap test, positive HPV test or any history of cervical dysplasia
- Women with an intact cervix (patients who have undergone previous LEEP, cone and/or cryotherapy are eligible)
- Women of childbearing potential must have a negative urine or serum pregnancy test
- Women who are at least 21 years of age or older
- Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)
Key exclusion criteria (5 listed)
- Women < 21 years of age
- Women who have undergone a hysterectomy with removal of the cervix
- Women with a known allergy to proflavine, acriflavine, or iodine
- Women who are pregnant or nursing
- Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
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 |
|---|---|---|
| ProflavineAlso: Proflavine hemisulfateProflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed. | Drug | High-Resolution Microendoscopy (HRME) |
| High-Resolution Microendoscopy (HRME)High-resolution microendoscopy imaging procedure performed after colposcopy exam. Standard colposcopy procedure will then continue. Entire HRME imaging procedure should add less than 10 minutes to the standard colposcopy exam. | Procedure or surgery | High-Resolution Microendoscopy (HRME) |
Primary outcome
Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME)
Time frame: 1 day
Successful outcome defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis.
Results and safety
The study was stopped early (reason given: PI has left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- University of Texas Medical Branch web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ana M Rodriguez, MD principal investigator
University of Texas Medical Branch (UTMB)
Kathleen Schmeler, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Proflavine and High-Resolution Microendoscopy (HRME) in people with Malignant Neoplasms of Female Genital Organs, run by The University of Texas Medical Branch, Galveston 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Jan 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI has left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the High-Resolution Microendoscopy (HRME) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2025.