HPV, Anal Dysplasia and Anal Cancer
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A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia
Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using The BARRX™ Anorectal Wand (Clinical Protocol 01-2017) AUGUST 31, 2017 Page 1 of 40 Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia PROTOCOL SIGNATURE PAGE I, , Principal Investigator at site , agree to conduct and follow this protocol: PROTOCOL 01-2017: A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for Anal Intraepithelial Neoplasia using the Barrx™ Anorectal Wand as written according to FDA guidelines. I understand that no deviations from the above protocol may be made without written permission from the Protocol Chair(s). _________________________________ _____________________ Signature Date (mm/dd/yyyy) Page 2 of 40 Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia P ROT O COL S U M M ARY Title A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for Anal Intraepithelial Neoplasia using the Barrx™ Anorectal Wand Design Multi-center prospective trial involving up to 70 subjects Subject Population HIV-positive and HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN) containing at least one high- grade squamous intraepithelial lesions (HSIL) involving the squamocolumnar junction (SCJ). Objective Assess the safety, and efficacy of circumferential radiofrequency ablation (RFA) to the anal canal using the FDA cleared Barrx™ Anorectal Wand to eradicate anal -
Clinical Reviewer: [Joohee Lee ] STN: [125508/153 ]
Clinical Reviewer: [Joohee Lee ] STN: [125508/153 ] Application sBLA Type STN 125508/153 CBER February 1, 2016 Received Date PDUFA Goal December 1, 2016 Date Division / DVRPA /OVRR Office Priority Review No Reviewer Joohee Lee Name(s) Review October 6, 2016 Completion Date / Stamped Date Supervisory Concurrence Lucia Lee, M.D., Team Leader, CRB1 Jeff Roberts, M.D., Chief, CRB1 Applicant Merck Established Human Papillomavirus 9-valent Vaccine, Recombinant Name (Proposed) Gardasil 9 Trade Name Pharmacologic Vaccine Class Page i Clinical Reviewer: [Joohee Lee ] STN: [125508/153 ] Formulation(s), A 0.5 mL dose contains: including Recombinant virus-like particles (VLPs) of the major capsid (L1) Adjuvants, etc protein of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58)* adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS) *Amounts of HPV type L1 protein are as follows: 30 mcg/40mcg/60mcg/40mcg/20mcg/20mcg/20mcg/20mcg/20mcg, respectively. Dosage 0.5-mL suspension for intramuscular injection as a single-dose Form(s) and vial and prefilled syringe Route(s) of Administration Dosing Two-dose regimen: 0 and 6 to 12 months Regimen A 3- dose regimen (0, 2 and 6 months) is approved for use in individuals 9 through 26 years of age (STN 125508/0) Page ii Clinical Reviewer: [Joohee Lee ] STN: [125508/153 ] Indication(s) and Intended This supplement introduces a 2-dose regimen in addition to the Population(s) licensed 3-dose regimen. The intended population for the 2- dose regimen is girls and boys 9 through 14 years of age. -
Detail Report
Supplemental Update Report CR Number: 2012319113 Implementation Date: 16-Jan-19 Related CR: 2012319113 MedDRA Change Requested Add a new SMQ Final Disposition Final Placement Code # Proposed SMQ Infusion related reactions Rejected After Suspension MSSO The proposal to add a new SMQ Infusion related reactions is not approved after suspension. The ICH Advisory Panel did approve this SMQ topic to go into the development phase and it Comment: underwent testing in three databases (two regulatory authorities and one company). However, there were numerous challenges encountered in testing and the consensus decision of the CIOMS SMQ Implementation Working Group was that the topic could not be developed to go into production as an SMQ. Most notably, in contrast to other SMQs, this query could not be tested using negative control compounds because it was not possible to identify suitable compounds administered via infusion that were not associated with some type of reaction. In addition, there is no internationally agreed definition of an infusion related reaction and the range of potential reactions associated with the large variety of compounds given by infusion is very broad and heterogenous. Testing was conducted on a set of around 500 terms, the majority of which was already included in Anaphylactic reaction (SMQ), Angioedema (SMQ), and Hypersensitivity (SMQ). It proved difficult to identify potential cases of infusion related reactions in post-marketing databases where the temporal relationship of the event to the infusion is typically not available. In clinical trial databases where this information is more easily available, users are encouraged to provide more specificity about the event, e.g., by reporting “Anaphylactic reaction” when it is known that this event is temporally associated with the infusion. -
NCCN Guidelines for Patients Anal Cancer
NCCN GUIDELINES FOR PATIENTS® 2021 Anal Cancer Presented with support from: Available online at NCCN.org/patients Ü Anal Cancer It's easy to get lost in the cancer world Let NCCN Guidelines for Patients® be your guide 9 Step-by-step guides to the cancer care options likely to have the best results 9 Based on treatment guidelines used by health care providers worldwide 9 Designed to help you discuss cancer treatment with your doctors NCCN Guidelines for Patients® Anal Cancer, 2021 1 About National Comprehensive Cancer Network® NCCN Guidelines for Patients® are developed by the National Comprehensive Cancer Network® (NCCN®) NCCN Clinical Practice NCCN Guidelines NCCN Guidelines in Oncology for Patients (NCCN Guidelines®) 9 An alliance of leading 9 Developed by doctors from 9 Present information from the cancer centers across the NCCN cancer centers using NCCN Guidelines in an easy- United States devoted to the latest research and years to-learn format patient care, research, and of experience 9 For people with cancer and education 9 For providers of cancer care those who support them all over the world Cancer centers 9 Explain the cancer care that are part of NCCN: 9 Expert recommendations for options likely to have the NCCN.org/cancercenters cancer screening, diagnosis, best results and treatment Free online at Free online at NCCN.org/patientguidelines NCCN.org/guidelines and supported by funding from NCCN Foundation® These NCCN Guidelines for Patients are based on the NCCN Guidelines® for Anal Cancer, Version 1.2021 — February 16, 2021. © 2021 National Comprehensive Cancer Network, Inc. All rights reserved. -
What Is Anal Cancer?
cancer.org | 1.800.227.2345 About Anal Cancer Overview and Types If you've been diagnosed with anal cancer or are worried about it, you likely have a lot of questions. Learning some basics is a good place to start. ● What Is Anal Cancer? Research and Statistics See the latest estimates for new cases of anal cancer and deaths in the US and what research is currently being done. ● Key Statistics for Anal Cancer ● What’s New in Anal Cancer Research? What Is Anal Cancer? Anal cancer is a type of cancer that starts in the anus. Cancer starts when cells in the body begin to grow out of control. To learn more about how cancers start and spread, see What Is Cancer?1 Normal structure and function of the anus 1 ____________________________________________________________________________________American Cancer Society cancer.org | 1.800.227.2345 The anus is the opening at the lower end of the intestines. It's where the end of the intestines connect to the outside of the body. As food is digested, it passes from the stomach to the small intestine. It then moves from the small intestine into the main part of the large intestine (called the colon). The colon absorbs water and salt from the digested food. The waste matter that's left after going through the colon is known as feces or stool. Stool is stored in the last part of the large intestine, called the rectum. From there, stool is passed out of the body through the anus as a bowel movement. Gastrointestinal system (GI system) Structures of the anus The anus is connected to the rectum by the anal canal. -
Anal Cytology in Women with Cervical Intraepithelial Or Invasive Cancer
ORIGINAL ARTICLE J Bras Patol Med Lab, v. 51, n. 5, p. 315-322, October 2015 Anal cytology in women with cervical intraepithelial or invasive cancer: interobserver agreement Citologia anal em mulheres com neoplasia intraepitelial ou invasiva cervical: concordância interobservadores 10.5935/1676-2444.20150051 Sandra A. Heráclio1; Fátima Regina G. Pinto2; Kristiane Cahen2; Letícia Katz2; Alex Sandro R. Souza1, 3 1. Instituto de Medicina Integral Professor Fernando Figueira (Imip). 2. Laboratório Central de Saúde Pública de Pernambuco (Lacen-PE). 3. Universidade Federal de Pernambuco (UFPE). ABSTRACT Introduction: Incidence rates of anal cancer have been rising worldwide in the last 20 years. Due to embryological, histological and immunohistochemical similarities between the anal canal and the cervix, routine screening with anal cytology for precursor lesions in high-risk groups has been adopted. Objective: To determine interobserver agreement for the diagnosis of anal neoplasia by anal cytology. Material and methods: A cross-sectional observational study was conducted in 324 women with cervical intraepithelial or invasive cancers, for screening of anal cancer, from December 2008 to June 2009. Three hundred twenty-four cytological samples were analyzed by three cytopathologists. Cytological evaluation was based on the revised Bethesda terminology; samples were also classified into negative and positive for atypical cells. We calculated the kappa statistic with 95% confidence interval (95% CI) to assess agreement among the three cytopathologists. Results: Interobserver agreement in the five categories of the Bethesda terminology was moderate (kappa for multiple raters: 0.6). Agreement among cytopathologists 1, 2 and 3 with a consensus diagnosis was strong (kappa: 0.71, 0.85 and 0.82, respectively). -
Infectious Gastroenteritis Generalised Anxiety Disorder HIV Smoking Associated Cancers
BEST PRACTICE 25 DECEMBER 2009 Infectious gastroenteritis Generalised anxiety disorder HIV bpac nz Smoking associated cancers better medicin e Editorial Team Tony Fraser Professor Murray Tilyard We would like to acknowledge the following people for Clinical Advisory Group their guidance and expertise in developing this edition: Michele Cray Dr Shaun Costello, Dunedin Serena Curtis-Lemuelu Dr Edward Coughlan, Christchurch Dr Rosemary Ikram Professor Tony Dowell, Wellington Dr Cam Kyle Dr Rosemary Ikram, Christchurch Dr Chris Leathart Mr William Pearce, Christchurch Dr Lynn McBain Dr Alan Pithie, Christchurch Adam McRae Dr Gabrielle Ruben, Wellington Janet Maloney-Moni Assoc. Professor Mark Thomas, Auckland Dr Peter Moodie Dr Robyn Toomath, Wellington Associate Professor Jim Reid Dr Neil Whittaker, GP Reviewer, Nelson Associate Professor David Reith Assoc. Professor Michael Williams, Dunedin Professor Murray Tilyard Programme Development Team Rachael Clarke Peter Ellison Best Practice Journal (BPJ) Rebecca Harris Julie Knight ISSN 1177-5645 Noni Richards BPJ, Issue 25, December 2009 Dr Tom Swire Dr AnneMarie Tangney nz Dr Sharyn Willis BPJ is published and owned by bpac Ltd Dave Woods Level 8, 10 George Street, Dunedin, New Zealand. Report Development Team Bpacnz Ltd is an independent organisation that promotes health Justine Broadley care interventions which meet patients’ needs and are evidence Todd Gillies based, cost effective and suitable for the New Zealand context. Lana Johnson We develop and distribute evidence based resources which describe, facilitate and help overcome the barriers to best Web practice. Gordon Smith Bpacnz Ltd is currently funded through contracts with PHARMAC Design and DHBNZ. Michael Crawford Bpacnz Ltd has five shareholders: Procare Health, South Link Management and Administration Health, IPAC, the University of Otago and Pegasus Health. -
Pathology of Anal Cancer
Pathology of Anal Cancer a b Paulo M. Hoff, MD, PhD , Renata Coudry, MD, PhD , a, Camila Motta Venchiarutti Moniz, MD * KEYWORDS Anal cancer Anal squamous intraepithelial neoplasia Squamous cell carcinoma Human papilloma virus (HPV) Molecular KEY POINTS Anal cancer is an uncommon tumor, squamous cell carcinoma (SCC) being the most frequent histology corresponding to 80% of all cases. Human papilloma virus (HPV) infection plays a key role in anal cancer development, en- coding at least three oncoproteins with stimulatory properties. SCC expresses CK5/6, CK 13/19, and p63. P16 is a surrogate marker for the presence of HPV genome in tumor cells. INTRODUCTION Anal cancer accounts for approximately 2.4% of gastrointestinal malignancies.1 Although anal cancer is a rare tumor, its frequency is increasing, especially in high- risk groups.2 Tumors in this location are generally classified as anal canal or anal margin. Squamous cell carcinoma (SCC) is the predominant type of tumor and shares many features with cervical cancer. Oncogenic human papilloma virus (HPV) infection plays a major role in both tumors.3 HIV infection is associated with a higher frequency of HPV-associated premalignant lesions and invasive tumors.4 Normal Anatomy of the Anus The anal canal is the terminal part of the large intestine and is slightly longer in male than in female patients. It measures approximately 4 cm and extends from the rectal ampulla (pelvic floor level) to the anal verge, which is defined as the outer open- ing of the gastrointestinal tract. The anal verge is at the level of the squamous- mucocutaneous junction with the perianal skin.5,6 The authors have nothing to disclose. -
Insights Into the Management of Anorectal Disease in the Coronavirus 2019 Disease Era
University of Massachusetts Medical School eScholarship@UMMS COVID-19 Publications by UMMS Authors 2021-07-09 Insights into the management of anorectal disease in the coronavirus 2019 disease era Waseem Amjad Albany Medical Center Et al. Let us know how access to this document benefits ou.y Follow this and additional works at: https://escholarship.umassmed.edu/covid19 Part of the Digestive System Diseases Commons, Gastroenterology Commons, Infectious Disease Commons, Telemedicine Commons, and the Virus Diseases Commons Repository Citation Amjad W, Haider R, Malik A, Qureshi W. (2021). Insights into the management of anorectal disease in the coronavirus 2019 disease era. COVID-19 Publications by UMMS Authors. https://doi.org/10.1177/ 17562848211028117. Retrieved from https://escholarship.umassmed.edu/covid19/285 Creative Commons License This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License This material is brought to you by eScholarship@UMMS. It has been accepted for inclusion in COVID-19 Publications by UMMS Authors by an authorized administrator of eScholarship@UMMS. For more information, please contact [email protected]. TAG0010.1177/17562848211028117Therapeutic Advances in GastroenterologyW Amjad, R Haider 1028117research-article20212021 Advances and Future Perspectives in Colorectal Cancer Special Collection Therapeutic Advances in Gastroenterology Review Ther Adv Gastroenterol Insights into the management of anorectal 2021, Vol. 14: 1–13 https://doi.org/10.1177/17562848211028117DOI: 10.1177/ disease in the coronavirus 2019 disease era https://doi.org/10.1177/1756284821102811717562848211028117 © The Author(s), 2021. Article reuse guidelines: Waseem Amjad, Rabbia Haider, Adnan Malik and Waqas T. Qureshi sagepub.com/journals- permissions Abstract: Coronavirus 2019 disease (COVID-19) has created major impacts on public health. -
Anal Cancer, HIV, and Gay
treatment ISSUES SEPTEMBER09 Treatment AnalISSUES cancer, HIV, and gay/bisexual men By Liz Margolies, LCSW, and Bill Goeren, LCSW In the general population, anal cancer is a rare disease. has decreased overall mortality from HIV, it has not Few people knew about it before Farrah Fawcett made reduced the incidence of anal squamous cell carcinoma public her struggle with the illness. Among men who (SCC).4 And, since it is spread through sexual skin-to- have sex with men (MSM), and especially HIV-positive skin contact, condom use only partially reduces the risk MSM, the incidence of anal cancer is significantly more of transmission. Other factors that increase the risk of prevalent and increasing annually.1 However, the major- anal cancer include a high number of sex partners, and ity of gay and bisexual men know little about the use of alcohol, drugs and tobacco. Although many men disease, have never been tested for it, nor know that have no obvious symptoms, one of the most common screening tests exit. Health care professionals, too, manifestations of HPV infection is genital warts which remain divided on how and whether to screen for it. In can affect the anus, the penis and/or the peritoneum, a fact, a standardized screening protocol for anal cancer does not yet exist. HIV-positive MSM are 40 times Each year anal cancer is diagnosed in about two peo- more likely to be diagnosed ple out of every 100,000 people in the general popula- with anal cancer. tion. HIV negative MSM are 20 times more likely to be diagnosed with anal cancer. -
Incidence of Recurrent High-Grade Anal Dysplasia in HIV-1-Infected Men and Women Following Infrared Coagulation Ablation: a Retrospective Cohort Study
pathogens Article Incidence of Recurrent High-Grade Anal Dysplasia in HIV-1-Infected Men and Women Following Infrared Coagulation Ablation: A Retrospective Cohort Study Javier Corral 1,2,3,*, David Parés 1,2,3, Francesc García-Cuyás 1,2, Boris Revollo 2,4, Ana Chamorro 2,4, Carla Lecumberri 2,5 , Antoni Tarrats 2,5, Eva Castella 6, Marta Piñol 1,2, Bonaventura Clotet 2,3,7, Sebastià Videla 2,8,*,† and Guillem Sirera 2,4,† 1 Department of General Surgery, Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain; [email protected] (D.P.); [email protected] (F.G.-C.); [email protected] (M.P.) 2 Lluita contra la Sida Foundation, Hospital Universitari Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain; brevollo@flsida.org (B.R.); achamorro@flsida.org (A.C.); [email protected] (C.L.); [email protected] (A.T.); [email protected] (B.C.); gsirera@flsida.org (G.S.) 3 School of Medicine, Universitat Autónoma de Barcelona (UAB), Edifici M, Av. de Can Domènech, Bellaterra, 08193 Barcelona, Spain 4 HIV Clinical Unit, Department of Medicine, University Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain 5 Department of Obstetrics and Gynaecology, Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain 6 Department of Pathology, Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, Citation: Corral, J.; Parés, D.; 08916 Barcelona, Spain; [email protected] García-Cuyás, F.; Revollo, B.; 7 Retrovirology Laboratory IrsiCaixa Foundation, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain Chamorro, A.; Lecumberri, C.; Tarrats, 8 Department of Clinical Pharmacology, Bellvitge University Hospital/IDIBELL/University of Barcelona, A.; Castella, E.; Piñol, M.; Clotet, B.; Hospitalet de Llobregat, Gran Via de les Corts Catalanes 199–203, 08907 Barcelona, Spain et al. -
Use of Human Papillomavirus Ge
Use of human papillomavirus genotyping and biomarkers for targeted screening of anal dysplasia in human immunodeficiency virus-infected patients Clarisse Dupin, Laurent Siproudhis, Sébastien Hénno, Sophie Minjolle, Cédric Arvieux, Pierre Tattevin To cite this version: Clarisse Dupin, Laurent Siproudhis, Sébastien Hénno, Sophie Minjolle, Cédric Arvieux, et al.. Use of human papillomavirus genotyping and biomarkers for targeted screening of anal dysplasia in human immunodeficiency virus-infected patients. Digestive and Liver Disease, WB Saunders, 2015, 47(5), pp.423-428. 10.1016/j.dld.2015.01.150. hal-01147275 HAL Id: hal-01147275 https://hal-univ-rennes1.archives-ouvertes.fr/hal-01147275 Submitted on 22 Oct 2015 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Use of human papillomavirus genotyping and biomarkers for targeted screening of anal dysplasia in human immunodeficiency virus-infected patients Clarisse Dupin,a,b, Laurent Siproudhis,b,c Sébastien Henno,b,d Sophie Minjolle,a,b Cédric Arvieux,b,e Pierre Tattevinb,e Department of Virology, Pontchaillou