- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420665
Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
If you are found to be eligible to take part in this study, you will first have your scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.
You will then have proflavine hemisulfate solution (contrast dye) applied to your cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This should add about 10 minutes to the total procedure time.
The HRME images will be stored in an electronic database and used for research. The images will be deidentified and only the MD Anderson staff will have access. This data will be stored in the database indefinitely (forever).
Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your standard of care using very small forceps (a medical tool that is like tongs). If the exam shows no abnormalities, a normal area will be biopsied.
The study doctor will talk to you about the results of the HRME imaging, colposcopy, and biopsy/ies.
There will be no change to the planned standard-of-care colposcopy and biopsy.
Researchers will also collect information from your medical record about the colposcopy, surgery, the status of the disease, and demographics (such as your age).
Follow-Up:
About 1 month after the study procedure, the study staff will contact you by phone to ask how you are doing. The call should last about 5 minutes.
Length of Study:
Your active participation in this study will be over after the biopsy.
This is an investigational study. Proflavine hemisulfate is not FDA approved or commercially available. The HRME device is not FDA approved or commercially available. Both are currently being used for research purposes only.
Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD Anderson and up to 400 will take part at the Harris Health System.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Houston, Texas, United States, 77026
- Lyndon B. Johnson General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS)
- Women of childbearing potential must have a negative 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)
Exclusion Criteria:
- Women < 21 years of age
- Women with a known allergy to proflavine or acriflavine
- Women who are pregnant or nursing
- Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-Resolution Microendoscopy (HRME) + Colposcopy
Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix.
Participants undergo standard colposcopy and abnormal lesions noted by quadrant.
Then 0.01% proflavine applied topically to the cervix.
High-resolution microendoscopy (HRME) then performed.
HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings.
Study staff follow up with participant by phone one month after procedure.
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0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.
HRME images obtained from one visually normal cervical site, and from up to 3 visually abnormal lesions based on exam and/or colposcopic findings.
Other Names:
Study staff follow up with participant by phone one month after procedure.
Colposcopy performed after visual inspection of cervix.
3 - 5% added to cervix before visual inspection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance Between the Diagnosis Using HRME Imaging and the Most Severe Histologic Diagnosis ( Concordance rate monitored using method described by Thall et al. (1995))
Time Frame: 1 day
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To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis.
That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy.
Target concordance rate is 70%.
Concordance rate monitored using method described by Thall et al. (1995), and trial stopped if concordance rate is less than 70%.
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1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Uterine Cervical Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Anticarcinogenic Agents
- Proflavine
- Acetic Acid
- Retinol acetate
Other Study ID Numbers
- 2014-0368
- HHSN261200800001E (Other Identifier: NIAID)
- 1R01CA186132 (U.S. NIH Grant/Contract)
- NCI-2015-00681 (Registry Identifier: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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