Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 10/19/2018 |
| Start Date: | October 25, 2016 |
| End Date: | July 2020 |
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.
"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.
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.
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.
Inclusion Criteria:
1. Women with an abnormal Pap test, positive HPV test or any history of cervical
dysplasia
2. Women with an intact cervix (patients who have undergone previous LEEP, cone and/or
cryotherapy are eligible)
3. Women of childbearing potential must have a negative urine or serum pregnancy test
4. Women who are at least 21 years of age or older
5. Ability to understand and the willingness to provide informed consent and sign a
written Informed Consent Document (ICD)
6. 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
Exclusion Criteria:
1. Women < 21 years of age
2. Women who have undergone a hysterectomy with removal of the cervix
3. Women with a known allergy to proflavine, acriflavine, or iodine
4. Women who are pregnant or nursing
5. Patients unable or unwilling to provide informed consent or sign a written Informed
Consent Document (ICD)
We found this trial at
1
site
McAllen, Texas 78501
Phone: 409-772-6767
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