E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM (ELAVI-67)
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|ClinicalTrials.gov Identifier: NCT03357991|
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : December 7, 2017
|Condition or disease|
|HPV - Anogenital Human Papilloma Virus Infection HSIL, High Grade Squamous Intraepithelial Lesions Anal Cancer Hiv|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||355 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Performance of E6/E7 mRNA to Detect Anal High-Grade Intraepithelial Lesions and Cost-effectiveness Analysis of a New Screening Strategy for Anal Cancer in HIV Positive Men Who Have Sex With Men|
|Actual Study Start Date :||January 11, 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
- Determine the predictive value of HPV E6/E7 mRNA for the detection of HSIL and its ability to predict incident cases. [ Time Frame: 2-5 years ]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.
- Cost-effectiveness analysis of an anal cancer screening strategy based on HPV E6/E7 mRNA analysis. [ Time Frame: 2-5 years ]Cost-effectiveness analysis of an anal cancer screening strategy based on the selection of candidates for HRA according to the expression of the E6 / E7 mRNA, compared to the usual strategy based on cytology and DNA HPV detection.
Biospecimen Retention: Samples With DNA
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.
- Anal cytology: processed with Thinprep Pap Test (Hologic, Marlborough, Massachusetts, USA). The swab is deposited into preserved liquid based cytology: PreservCyt Solution.
- HRA with biopsy of suspicious lesions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357991
|Contact: Ana C Silva Klug||0034932607667 ext firstname.lastname@example.org|
|Contact: Maria Saumoy Linares||0034932607667 ext email@example.com|
|Hospital Universitary de bellvitge||Recruiting|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Contact: Ana C Silva Klug 0034932607667 ext 2859 firstname.lastname@example.org|
|Contact: Maria Saumoy Linares 0034932607667 ext 2887 email@example.com|
|Principal Investigator: Daniel Podzamczer Palter|
|Principal Investigator:||Daniel Podzamczer Palter||Hospital Universitari de Bellvitge|