MedDataX Logo

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

NCT ID: NCT03357991

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-11

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction: Anal cancer incidence is increasing in HIV-infected men who have sex with men (MSM). There are still no standardized criteria for anal cancer screening. Anal cytology has not shown enough sensitivity and specificity in the selection of patients who need more invasive procedures, as high resolution anoscopy (HRA). Human Papillomavirus (HPV) E6 and E7 oncogenes deregulation is a crucial factor in neoplasic lesions progression.

Objectives: 1)To assess the negative and positive predictive value of E6/E7 mRNA expression for high-grade squamous intraepithelial lesions (HSIL) and its capacity to predict the incidence of new HSIL during the follow-up 2)To analyze the cost-effectiveness of E6/E7 as a new screening strategy for anal cancer compared with usual strategies (cytology and DNA detection).

Methodology: Ambispective longitudinal study. Participants: HIV MSM from the outpatients HIV and STD Unit of Bellvitge Hospital. We include patients visited within the usual outpatient practice since January 2015 with a cytology stored following the Hospital protocol, as well as patients collected prospectively since January 2017. This methodological approach will let to reduce the time of inclusion and maximize follow-up time. Sample size calculated: 355 participants. Follow-up period: 2 to 5 years. At each visit an anal smear for cytology, HPV DNA detection (by Linear Array and Hybrid Capture) and E6/E7 mRNA expression and a HRA with biopsy of suspicious areas of dysplasia will be performed. The analysis of cost-effectiveness will be made with a Markov model that projects long-term cost and effectiveness for both strategies, the E6/E7 and conventional cytology plus detection of High Risk HPV.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Previous diagnosis of anal cancer.
* Treatment of anal intraepithelial lesions the 5 years before study inclusion.
* Suspect infiltrating anal cancer, requiring exploration under anesthesia and surgical removal for histological confirmation.
* History of diffuse ano-genital condylomatous disease the 5 years before study inclusion or presence at first visit.
* Other factors that could prevent correct diagnosis and monitoring of the anal dysplastic lesions (test intolerance, proctological pathology that does not allow HRA, etc.).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut d'Investigació Biomèdica de Bellvitge

OTHER

Sponsor Role collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Podzamczer Palter

PhD. Chief of the HIV and STD Unit (Infectious Disease Service)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Podzamczer Palter

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitary de bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ana C Silva Klug

Role: CONTACT

Phone: 0034932607667

Email: [email protected]

Maria Saumoy Linares

Role: CONTACT

Phone: 0034932607667

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ana C Silva Klug

Role: primary

Maria Saumoy Linares

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35545433 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI16/01056

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PR076/17

Identifier Type: -

Identifier Source: org_study_id