Cervical Intraepithelial Neoplasia Clinical Trial
— HRME-UH2Official title:
Point‐of‐Care, Real‐Time Optical Imaging to Enable Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings
Verified date | February 2017 |
Source | Barretos Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME. The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to women who have screened positive during a prior visit with the mobile screening unit. The mobile diagnostic and treatment unit will be constructed and maintained at BCH.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2016 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Women with an abnormal Pap test (atypical squamous cells of undetermined significance or more severe interpretations [=ASC-US]) 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 18 years of age or older 5. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD) Exclusion Criteria: 1. Women <18 years of age 2. Women who have undergone a hysterectomy with removal of the cervix 3. Women with a known allergy to proflavine or acriflavine 4. Women who are pregnant or nursing 5. Women unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital | M.D. Anderson Cancer Center, National Institutes of Health (NIH), William Marsh Rice University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment completion rate. | Treatment completion for screen-positive women invited to visit a mobile diagnostic and treatment unit in their local area compared to those who are asked to return to a central facility for diagnosis and treatment. | Participants will be followed for two years. | |
Secondary | Efficacy (ability to detect CIN 2+ in women with previous abnormal Pap test). | Efficacy of HRME in detecting CIN 2+ in women with previous abnormal Pap test. | 6 months |
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