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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03357991 |
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Date of registration:
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24/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM
ELAVI-67 |
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Scientific title:
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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 |
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Date of first enrolment:
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January 11, 2015 |
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Target sample size:
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355 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03357991 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Ana C Silva Klug |
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Address:
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Telephone:
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0034932607667 |
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Email:
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ana.silva@bellvitgehospital.cat |
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Affiliation:
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Name:
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Ana C Silva Klug |
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Address:
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Telephone:
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0034932607667 |
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Email:
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ana.silva@bellvitgehospital.cat |
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Affiliation:
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Name:
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Daniel Podzamczer Palter |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitari de Bellvitge |
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Key inclusion & exclusion criteria
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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.).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hiv
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HSIL, High Grade Squamous Intraepithelial Lesions
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Anal Cancer
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HPV - Anogenital Human Papilloma Virus Infection
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Cost-effectiveness analysis of an anal cancer screening strategy based on HPV E6/E7 mRNA analysis.
[Time Frame: 2-5 years]
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Secondary ID(s)
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PR076/17
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PI16/01056
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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