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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05556772
Other study ID # RG1122164
Secondary ID NCI-2021-14229RG
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date July 31, 2026

Study information

Verified date April 2024
Source Fred Hutchinson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 619
Est. completion date July 31, 2026
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 49 Years
Eligibility Inclusion Criteria: - Women ages 25 - 49 years old will be eligible to participate in the study - Women and transgender men 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Collection of blood; urine; cervical, anal, vaginal samples
Other:
Interview
Attend interview

Locations

Country Name City State
Dominican Republic Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP) "Dr. Huberto Bogaert Diaz" Santo Domingo

Sponsors (4)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Center Instituto Dermatológico Dominicano y Cirugía de Piel (IDCP), National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type Measure Description Time frame Safety issue
Other Detection of CIN2+ is improved by cervical imaging with automated visual evaluation that uses a machine learning algorithm vs colposcopy 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 At baseline
Other Assess overall burden of HPV disease 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 At baseline
Primary Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping 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). At baseline
Secondary Detection of cervical precancerous lesions (CIN3) by cytology vs HPV restricted genotyping 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). At baseline
Secondary Cross-sectional diagnostic accuracy of triage by dual staining among hrHPV positive WLWH to detect CIN2+ 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). At baseline
Secondary Diagnostic accuracy of dual staining triage among hrHPV positive WLWH to detect CIN2+ by specimen collected and reading approach 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. At baseline
Secondary Diagnostic accuracy of hrHPV genotyping to detect CIN2+ among WLWH by vaginal vs cervical sampling 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. At baseline
Secondary CIN2+ Incidence Estimate the cumulative incidence of newly detected CIN2+ over 2 years among women negative at previous time points. At 12 and 24 months
Secondary Detection of repeat CIN2+ Calculate the proportion positive a second time for CIN2+ at Month 12 or 24. At 12 and 24 months
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