HPV - Anogenital Human Papilloma Virus InfectionELAVI-67NCT03357991
E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM
An observational study of HPV - Anogenital Human Papilloma Virus Infection and HSIL, High Grade Squamous Intraepithelial Lesions, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HPV - Anogenital Human Papilloma Virus Infection, HSIL, High Grade Squamous Intraepithelial Lesions, Anal Cancer
- How many people
- 355 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2015to Jun 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men who have sex with men >= 18 years
- HIV documented infection
- Signature of the informed consent
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitary de bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Ana C Silva Klug, 0034932607667 ext. 2859, ana.silva@bellvitgehospital.cat
Maria Saumoy Linares, 0034932607667 ext. 2887, msaumoy@bellvitgehospital.cat
About this study
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
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.
Read the detailed description
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
- 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
- Medical subject headings
- Squamous Intraepithelial Lesions, Anus Neoplasms, Acquired Immunodeficiency Syndrome, Homosexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-5 years
Secondary outcomes (1)
Cost-effectiveness analysis of an anal cancer screening strategy based on HPV E6/E7 mRNA analysis.
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.
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start11 Jan 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV - Anogenital Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Principal investigator, Daniel Podzamczer Palter, Hospital Universitari de Bellvitge
- Investigators
- Daniel Podzamczer Palter, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357991
- Sponsor's protocol ID
- PR076/17
- Other IDs
- PI16/01056
- Acronym
- ELAVI-67
- Status last verified
- Dec 2017
- First submitted
- 24 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35545433
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03357991
- Acronym / sponsor ID
- ELAVI-67 / PR076/17
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 11 Jan 2015 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Men who have sex with men >= 18 years
- HIV documented infection
- Signature of the informed consent
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cost-effectiveness analysis of an anal cancer screening strategy based on HPV E6/E7 mRNA analysis.
Time frame: 2-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Derived from this study: PubMed 35545433Torres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Podzamczer Palter principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV - Anogenital Human Papilloma Virus Infection and HSIL, High Grade Squamous Intraepithelial Lesions, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana C Silva Klug (0034932607667 ext. 2859, ana.silva@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.