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Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico (CAMPO-101)

Primary Purpose

AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma, High Grade Anal Intraepithelial Neoplasia

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Biopsy

Biospecimen Collection - Anal

Biospecimen Collection - Cervical

Colposcopy

High Resolution Anoscopy

Imaging Technique

About this trial

This is an interventional screening trial for AIDS-Related Anal Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Condesa Iztapalapa Specialized ClinicRecruiting
Condesa Specialized Clinic
Instituto Nacional de Cancerologia (INCan)
University of Puerto Rico Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging, biospecimen collection, anoscopy and/or colposcopy

Arm Description

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

Outcomes

Primary Outcome Measures

Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05074264

First Posted

September 29, 2021

Last Updated

March 7, 2023

Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)

1. Study Identification

Unique Protocol Identification Number

NCT05074264

Brief Title

Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico

Acronym

CAMPO-101

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Patients with HIV are at high risk of becoming infected with human papillomavirus (HPV) in the cervix or anus where it can turn into cancer over several years. HPV causes changes to the cervix and anus, known as HSIL. This means that there is an area of abnormal tissue on the top layers of the cervix or anus. It is considered cervical or anal cancer if the abnormality spreads down into the layers of tissue below the top. If found early, many cases of HSIL can be treated before turning into cancer. Screening for cervical or anal cancer detection or HSIL associated with HPV may result in earlier treatment, if necessary, for patients living with HIV.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma, High Grade Anal Intraepithelial Neoplasia, High Grade Cervical Intraepithelial Neoplasia, HIV Infection

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Imaging, biospecimen collection, anoscopy and/or colposcopy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

Undergo biopsy

Intervention Type

Procedure

Intervention Name(s)

Biospecimen Collection - Anal

Other Intervention Name(s)

Biological Sample Collection, Biospecimen Collection

Intervention Description

Undergo collection of anal swabs

Intervention Type

Procedure

Intervention Name(s)

Biospecimen Collection - Cervical

Other Intervention Name(s)

Biological Sample Collection, Biospecimen Collection

Intervention Description

Undergo collection of cervical swabs

Intervention Type

Procedure

Intervention Name(s)

Colposcopy

Intervention Description

Undergo colposcopy

Intervention Type

Procedure

Intervention Name(s)

High Resolution Anoscopy

Other Intervention Name(s)

HRA

Intervention Description

Undergo high-resolution anoscopy

Intervention Type

Procedure

Intervention Name(s)

Imaging Technique

Other Intervention Name(s)

Diagnostic Imaging Technique, Imaging, Imaging Procedures, Medical Imaging

Intervention Description

Undergo cervical imaging

Primary Outcome Measure Information:

Title

Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)

Description

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joel Palefsky, MD

Phone

(415) 476-8885

Joel.Palefsky@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Palefsky, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

Condesa Iztapalapa Specialized Clinic

City

Ciudad de mexico

State/Province

Cdmx

ZIP/Postal Code

09730

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

jorge.salmec@gmail.com

First Name & Middle Initial & Last Name & Degree

Jorge Salmerón, MD, MSc, DSc

Facility Name

Condesa Specialized Clinic

City

Ciudad de México

State/Province

Cdmx

ZIP/Postal Code

06170

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Contact:

agonzalez@sersalud.df.gob.mx

First Name & Middle Initial & Last Name & Degree

Andrea Gónzalez, MD

Facility Name

Instituto Nacional de Cancerologia (INCan)

City

Ciudad de México

State/Province

Cdmx

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alrejandro Garcia-Carranca, PhD

Facility Name

University of Puerto Rico Comprehensive Cancer Center

City

San Juan

ZIP/Postal Code

00936-3027

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ana.ortiz7@upr.edu

First Name & Middle Initial & Last Name & Degree

Ana P. Ortiz, MPH, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico

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