Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico (CAMPO-101)
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| ClinicalTrials.gov Identifier: NCT05074264 |
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Recruitment Status :
Recruiting
First Posted : October 12, 2021
Last Update Posted : January 26, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| AIDS-Related Anal Carcinoma AIDS-Related Cervical Carcinoma High Grade Anal Intraepithelial Neoplasia High Grade Cervical Intraepithelial Neoplasia HIV Infection | Procedure: Biopsy Procedure: Biospecimen Collection - Anal Procedure: Biospecimen Collection - Cervical Procedure: Colposcopy Procedure: High Resolution Anoscopy Procedure: Imaging Technique | Not Applicable |
PRIMARY OBJECTIVE:
I. Evaluate the most efficient algorithm combining point-of-care (POC) HPV-based screening with several triage alternatives: cytology, E6 and/or E7 oncoprotein detection and S5 methylation, to improve the current screening program for detection of anogenital HPV-related cancers and pre-cancers, in men and women living with HIV in Mexico and Puerto Rico.
EXPLORATORY OBJECTIVE:
I. Evaluate artificial intelligence-based algorithms based on cell-phone images of the cervix for their sensitivity, specificity, and negative and positive predictive values for cervical cancers and precancers in women living with HIV in Mexico and Puerto Rico.
OUTLINE: Patients receive standard medical procedures based on anatomy at time of enrollment.
GROUP I (WOMEN LIVING WITH HIV (WLWH)): Patients undergo collection of cervical images, 3 cervical anal swabs and 3 anal swabs for real-time testing of high-risk (hr) HPV over 90 minutes. Patients with a positive hrHPV test on their cervical swab undergo colposcopy and biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for low-grade squamous intraepithelial lesion (LSIL) or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo standard of care (SOC) treatment or enroll in additional studies when they are open to accrual.
GROUP II (MEN LIVING WITH HIV (MLWH)): Patients undergo collection of 3 anal swabs for real-time testing of high-risk HPV over 90 minutes. Patients with a positive hrHPV test undergo high-resolution anoscopy with biopsies of visible lesions. Patients with hrHPV negative test may undergo high-resolution anoscopy. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3000 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Optimization of Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People Living With HIV in Mexico and Puerto Rico |
| Actual Study Start Date : | November 30, 2021 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Imaging, biospecimen collection, anoscopy and/or colposcopy
Patients undergo collection of cervical images (if applicable), 3 cervical anal swabs (if applicable) and 3 anal swabs for real-time testing of HPV or hrHPV over 90 minutes. Patients with a positive HPV or hrHPV test on undergo biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for LSIL or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual
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Procedure: Biopsy
Undergo biopsy Procedure: Biospecimen Collection - Anal Undergo collection of anal swabs
Other Names:
Procedure: Biospecimen Collection - Cervical Undergo collection of cervical swabs
Other Names:
Procedure: Colposcopy Undergo colposcopy Procedure: High Resolution Anoscopy Undergo high-resolution anoscopy
Other Name: HRA Procedure: Imaging Technique Undergo cervical imaging
Other Names:
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- Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL) [ Time Frame: Up to 3 years ]Will assess a screening algorithm with an optimal combination of: point of care high-risk (hr) HPV testing, extended hrHPV genotyping, cytology, progression markers protein E6 and S5 methylation score, to identify cervical and/or anal HSIL or cancer. Different contingency tables will be prepared to describe the statistical relationship between hrHPV infection and HSIL positive status. Using the Bayes Rule, the predicted values will the computed using the prevalence of HSIL positive (overall and per country), where prevalence is the probability of currently being HSIL positive regardless of the duration of time one has the disease. The positive Diagnostic Likelihood Ratios (DLR) and the Negative Diagnostic Likelihood Ratio will be computed to determine the best strategy combining sensitivity and specificity. The 95% confidence intervals of DLR+ will be computed using the log approach.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider
- Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone [e.g., Truvada], which is exclusionary);
- HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL
- Any locally licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay
- NOTE: A "licensed" assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay or an assay approved by the relevant local health authority
- Age 21 years or older. Cervical HSIL/cancer screening does not usually begin until 20 years of age or older. Also, anal HSIL/cancer screening among high risk individuals such as people living with HIV is recommended for those 25 years of age or older. Children under the age of 18 are at low risk of developing cervical or anal HSIL/cancer and will not benefit from the kind of screening planned for this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky score >= 70%)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Participants who have undergone hysterectomy
- History of anal cancer, penile, vulvar, vaginal, or cervical cancer
- Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment
- Inability in the opinion of the study investigator of the participant to comply with study requirements
- Participants who are pregnant (a urine pregnancy test will be provided to participants aged 60 years or less) or within 2 months being post-partum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074264
| Contact: Joel Palefsky, MD | (415) 476-8885 | Joel.Palefsky@ucsf.edu |
| United States, California | |
| University of California, San Francisco | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Joel Palefsky, MD 415-476-8885 Joel.Palefsky@ucsf.edu | |
| Contact 877-827-3222 cancertrials@ucsf.edu | |
| Principal Investigator: Joel Palefsky, MD | |
| Sub-Investigator: George Sawaya, MD | |
| Mexico | |
| National Institute of Public Health | Not yet recruiting |
| Santa María Ahuacatitlán, Cuernavaca, Morelos, Mexico, 62100 | |
| Contact: Jorge Salmerón, MD, MSc, DSc +52 1 55 4365 9893 jorge.salmec@gmail.com | |
| Principal Investigator: Jorge Salmerón, MD, MSc, DSc | |
| Puerto Rico | |
| University of Puerto Rico Comprehensive Cancer Center | Recruiting |
| San Juan, Puerto Rico, 00936-3027 | |
| Contact: Ana P. Ortiz, MPH, PhD 787-407-5002 ana.ortiz7@upr.edu | |
| Principal Investigator: Ana P. Ortiz, MPH, PhD | |
| Principal Investigator: | Joel Palefsky, MD | University of California, San Francisco |
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT05074264 |
| Other Study ID Numbers: |
21622 NCI-2020-13805 ( Registry Identifier: NCI Clinical Trial Reporting Program (CTRP) ) ULACNet-101 ( Other Identifier: Division of Cancer Prevention ) U54CA242646 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 12, 2021 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Carcinoma Neoplasms Carcinoma in Situ Cervical Intraepithelial Neoplasia Anus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Rectal Neoplasms Colorectal Neoplasms |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |