Malignant Female Reproductive System Neoplasm
Conditions
Brief summary
This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.
Detailed description
OUTLINE: Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.
Interventions
PROCEDUREBiospecimen Collection
Collection of blood; urine; cervical, anal, vaginal samples
OTHERInterview
Attend interview
Sponsors
National Cancer Institute (NCI)
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Women ages 25 - 49 years old will be eligible to participate in the study * Women living with HIV who have an intact cervix * Intent to reside in the Santo Domingo area * Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible * Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria
Exclusion criteria
* Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded * Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study * Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study * Women who have no history of vaginal sexual exposure will not be eligible for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping | At baseline | Compare performance characteristics of two screening strategies. Comparison between dichotomous tests will be summarized by: (i) the true positive rate (TPR) and (ii) the false positive rate (FPR). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess overall burden of HPV disease | At baseline | Prevalence of non-cervical visible lesions, histological confirmation of non-cervix lesions (at the vulva, vagina, and peri-anal region), and hrHPV testing status at the vagina and anal canal |
| Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping | At baseline | Compare performance characteristics of two screening strategies. Comparison between dichotomous tests will be summarized by: (i) the true positive rate (TPR) and (ii) the false positive rate (FPR). |
| Cross-sectional diagnostic accuracy of triage by dual staining among hrHPV positive WLWH to detect CIN2+ | At baseline | Estimate the diagnostic accuracy parameters (TPR, FPR, positive predictive value or PPV, negative predictive value or NPV) and their approximate 95% confidence intervals for the p16/Ki-67 dual staining triage strategy for WLWH who tested positive for restricted hrHPV genotyping at Month 0. Will also assess and compare the accuracy parameters (TPR/FPR) of the dual staining method as it applies to hrHPV16 positive WLWH versus those who are positive for other types of hrHPV in two-sample (unpaired) comparisons of proportions (two-sample proportion tests). |
| Detection of CIN2+ is improved by cervical imaging with automated visual evaluation that uses a machine learning algorithm vs colposcopy | At baseline | Post hoc evaluation not impacting treatment decision comparing colposcopy to image score by Cohen's kappa using a scale of normal, precancer+ and greyzone/low grade using a coordinated scale |
| Diagnostic accuracy of hrHPV genotyping to detect CIN2+ among WLWH by vaginal vs cervical sampling | At baseline | Calculate (i) the Cohen's kappa and (ii) the concordance correlation coefficient to calculate agreement between the two methods. Use the McNemar test to compare the overall agreement between them. |
| CIN2+ Incidence | At 12 and 24 months | Estimate the cumulative incidence of newly detected CIN2+ over 2 years among women negative at previous time points. |
| Detection of repeat CIN2+ | At 12 and 24 months | Calculate the proportion positive a second time for CIN2+ at Month 12 or 24. |
| Diagnostic accuracy of dual staining triage among hrHPV positive WLWH to detect CIN2+ by specimen collected and reading approach | At baseline | Calculate (i) the Cohen's kappa and (ii) the concordance correlation coefficient to calculate agreement between the two methods. Use the McNemar test to compare the overall agreement between them. |
Countries
Dominican Republic
Outcome results
None listed