Dataset Information

The Study of the Prevention of Anal Cancer in Homosexual Men

ABSTRACT: Interventions: High Resolution Anoscopy (HRA) is being used to determine if the study will provide important information to guide the possible future introduction of anal cancer screening program for gay men. The HRA examination takes about 20 minutes for perform. It is not generally painful, due to local anaesthesia given prior to the procedure. Mild, transient anal bleeding may occur, for 72 hours after the procedure. The HRA procedure is conducted at Baseline and all 4 follow up visits which occur 6 months after Baseline and then annually to 36 months. There is a very small risk of a significant post-procedure haemorrhage. During the seven days after the procedure, it is possible that this may increase the risk of HIV infection should the participant have unprotected receptive anal intercourse. The procedure itself, and awaiting the pathology result, may cause anxiety in some participants. After having this procedure the participants are advised not to have receptive anal intercourse for at least 7 days. As a result of this procedure some participants may be referred for treatment of anal abnormalities. Primary outcome(s): To determine if the study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men. This is assessed by the conduct of the high resolution anoscopy and the HPV test.[2018] Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

DISEASE(S): Cancer-bowel-anal,Incidence Of Hpv In Homosexual Men,Public Health-epidemiology,Anal Cancer

PROVIDER: 2460322 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Aim: We aim to compare current (MeDIP-seq), new (Illumina Infinium 450K BeadChip) and future (PacBio) methods for whole genome DNA methylation analysis. As the interest in determination of disease methylation profiles increases, the scope, advantages and limitations of these methods requires assessment. There are key questions to answer and specific challenges to overcome. For example, how much detail/resolution is sufficient to identify regions of differential methylation and regions of biological/medical significance within a sample? How much coverage of the genome is required for accurate methylation analysis? Is it important to confirm which regions of the genome are unmethylated in addition to focusing on those that are methylated? Loss of methylation may be of equal importance within the cell since this may also contribute to disease pathogenesis. A multi-method (affinity enrichment/bisulphite-conversion based/direct sequencing of methyl-cytosine) and technology platform (Illumina HiSeq/PacBio/Illumina Infinium BeadChip) comparison will enable us to determine the strengths and weakness of each method. We propose to compare four methods using two DNA samples from the Coriell Institute for Cell Repository to assess both current and future capabilities for whole genome methylation analysis in parallel: A) MeDIP-seq using Illumina HiSeq B) Illumina Infinium HumanMethylation 450K BeadChip and C) whole genome methylation sequencing using PacBio. Existing single molecule deep bisulphite sequencing data generated previously from these same samples at the WTSI for targeted regions (30-40 genes) on the human X chromosome will be used to assess performance of each method. The methods selected for this study will generate data covering a range of resolutions from a whole genome scan to array (target defined) resolution and up to single base pair, single molecule resolution; the highest level of detail possible with methods currently available.Samples: DNA from sibling pair GM01240 (female) and GM01240 (male).Requirements: Both samples will be analysed using;A.MeDIP-seq using Illumina HiSeq (one HiSeq lane, 75bp paired end, per sample) B.Illumina Infinium HumanMethylation 450K BeadChipWe are expecting a potentially unnecessary high coverage using one HiSeq lane per sample. However, for the MeDIP procedure we do not have a multiplexing procedure in place. Our requirements for PacBio sequencing have been discussed with and will be supported by the Sequencing Technology Development group.

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The Study of the Prevention of Anal Cancer in Homosexual Men

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