E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM

NCT03357991 | Unknown DMC

• 2 other identifiers: PR076/17PI16/01056
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the positive and negative predictive value of E6/E7 mRNA expression for anal HSIL and its capacity to predict incident HSIL in HIV + MSM. We also analyse the cost-effectiveness of this new screening strategy. It is an ambispective study with 355 participants and a follow-up period of 2 to 5 years.

Conditions

HPV - Anogenital Human Papilloma Virus Infection; HSIL, High Grade Squamous Intraepithelial Lesions; Anal Cancer; Hiv

Keywords

E6/E7 mRNA; anal cancer screening; men who have sex with men; cost-effectiveness analysis; High resolution anoscopy

Outcome Measures

Primary Outcomes (1)

• Determine the predictive value of HPV E6/E7 mRNA for the detection of HSIL and its ability to predict incident cases.

  Determination of HPV E6/E7 ARNm in anal samples of 355 HIV + MSM. Correlation of the detection of HPV E6/E7 ARNm with the diagnosis of HSIL in this patients performing anal cytology an HRA at the first visit and during the follow-up.

  2-5 years

Secondary Outcomes (1)

• Cost-effectiveness analysis of an anal cancer screening strategy based on HPV E6/E7 mRNA analysis.

  2-5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult HIV-infected MSM visited in the HIV Unit of Bellvitge's University Hospital and underwent routine anal cancer screening. Retrospective participants: patients attended between January 2015 and December 2016 and with part of the anal smear sample stored. Prospective participants: patients who start anal cancer screening during the inclusion period.

You may qualify if:

• Men who have sex with men \>= 18 years
• HIV documented infection
• Signature of the informed consent

You may not qualify if:

• Previous diagnosis of anal cancer.
• Suspect infiltrating anal cancer, requiring exploration under anesthesia and surgical removal for histological confirmation.
• Other factors that could prevent correct diagnosis and monitoring of the anal dysplastic lesions (test intolerance, proctological pathology that does not allow HRA, etc.).

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (1)

Hospital Universitary de bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Related Publications (1)

• Torres M, Silva-Klug A, Ferrer E, Saumoy M, Trenti L, Tous S, Esteban A, Baixeras N, Catala I, Vidal A, G Bravo I, Podzamczer D, de Sanjose S. Detecting anal human papillomavirus infection in men who have sex with men living with HIV: implications of assay variability. Sex Transm Infect. 2023 May;99(3):187-190. doi: 10.1136/sextrans-2021-055303. Epub 2022 May 11.

  PMID: 35545433 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. Detection of anal HPV * Hybrid Capture® 2 HPV DNA (QIAGEN Inc., Gaithersburg, Maryland; EE.UU): enzyme linked immunoabsorvent assay based on a sandwich hybridisation that allows a qualitative measure of DNA of 13 HPV. * Linear Array HPV Genotyping Test (Roche Molecular Systems Inc., Alameda, California, EE.UU): it detects a region within the HPV L1 that share 37 anogenital HPV genotypes. * Detection of E6/E7 VPH mRNA using APTIMA® HPV Test (Gen-Probe Inc., San Diego, California, EE.UU): it allows the qualitative detection of HPV E6/E7 mRNA from 14 high-risk HPVs. 2. Anal cytology: processed with Thinprep Pap Test (Hologic, Marlborough, Massachusetts, USA). The swab is deposited into preserved liquid based cytology: PreservCyt Solution. 3. HRA with biopsy of suspicious lesions

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Anus Neoplasms; Acquired Immunodeficiency Syndrome; Homosexuality

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Study Officials

• Daniel Podzamczer Palter

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Silva Klug

CONTACT

0034932607667; ana.silva@bellvitgehospital.cat

Maria Saumoy Linares

CONTACT

0034932607667; msaumoy@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Chief of the HIV and STD Unit (Infectious Disease Service)

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: January 11, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

ES (1)