Anal Cancer Early Detection, Diagnosis, and Staging Detection and Diagnosis
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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. -
High Resolution Anoscopy Overview
High Resolution Anoscopy Overview Naomi Jay, RN, NP, PhD University of California San Francisco Email: [email protected] Disclosures No Disclosures Definition of HRA Examination of the anus, anal canal and perianus using a colposcope with 5% acetic acid and Lugol’s solution. Basic Principles • Office-based procedure • Adapted from gynecologic colposcopy. • Validated for anal canal. • Similar terminology and descriptors. may be unfamiliar to non-gyn providers. • Comparable to vaginal and vulvar colposcopy. • Clinicians familiar with cervical colposcopy may be surprised by the difficult transition. Anal SCJ & AnTZ • Original vs. current SCJ less relevant. • TZ features less common, therefore more difficult to appreciate. • SCJ more subtle, difficult to see in entirety requires more manipulation & acetic acid. • Larger area of metaplastic changes overlying columnar epithelium compared to endocervix. • Most lesions found in the AnTZ. Atypical Metaplasia • Atypical metaplasia may indicate the presence of HSIL. • Radiate over distal rectum from SCJ. • Thin, may wipe off. • Features to look for indicating potential lesions: • Atypical clustered glands (ACG) • Lacy metaplastic borders (LM) • Epithelial Honeycombing (EH) Lugol’s. Staining • More utility in anus compared to cervix. • Adjunctive to help define borders, distinguish between possible LSIL/HSIL. • Most HSIL will be Lugol’s negative • LSIL may be Lugol’s partial or negative • Applied focally with small cotton swabs to better define an acetowhite lesion. •NOT a short cut to determine presence or absence of lesions, acetic acid is used first and is applied frequently. Anal vs. Cervical Characteristics • Punctation & Mosaic rarely “fine” mostly “coarse”. • Mosaic pattern mostly associated with HSIL. • Atypical vessels may be HSIL or cancer • Epithelial honeycombing & lacy metaplasia unique anal descriptors. -
Lower Gastrointestinal Tract
Lower Gastrointestinal Tract Hemorrhoids—Office Management and Review for Gastroenterologists Mitchel Guttenplan, MD, FACS 1 and Robert A Ganz, MD, FASGE 2 1. Medical Director, CRH Medical Corp; 2. Minnesota Gastroenterology, Chief of Gastroenterology, Abbott-Northwestern Hospital, Associate Professor of Medicine, University of Minnesota Abstract symptomatic hemorrhoids and anal fissures are very common problems. This article provides a review of the anatomy and physiology of the anorectum along with a discussion of the diagnosis and treatment of hemorrhoids and the commonly associated matters of anal sphincter spasm and fissures. The various office treatment modalities for hemorrhoids are discussed, as are the specifics of rubber band ligation (rBL), and a strategy for the office treatment of these problems by the gastroenterologist is given. The crh o’regan system™ is a technology available to the gastroenterologist that provides a safe, effective, and efficient option for the non-surgical treatment of hemorrhoids in the office setting. Keywords hemorrhoids, anal fissure, rubber band ligation, crh o’regan system™ Disclosure: Mitchel guttenplan is Medical Director of crh Medical Products corporation, the manufacturer of the crh o’regan system™. robert A ganz is a consultant to and holds equity in crh Medical Products corporation. Received: 2 november 2011 Accepted: 30 november 2011 Citation: Touchgastroentorology.com ; December, 2011. Correspondence: Mitchel guttenplan, MD, fAcs, 3000 old Alabama rd, suite 119 #183, Alpharetta, gA 30022-8555, us. e: [email protected] Diseases of the anorectum, including hemorrhoids and anal fissures, are experience also makes it clear that hemorrhoid sufferers frequently very common. The care of these entities is typically left to general and have additional anorectal issues that may both confuse the diagnosis colorectal surgeons. -
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. -
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. -
HPV, Anal Dysplasia and Anal Cancer
HPV, anal dysplasia FACT and anal cancer SHEET Published 2016 Summary Anal cancer typically develops over a period of years, beginning with a precancerous condition called anal dysplasia. CONTACT US Anal dysplasia occurs when clusters of abnormal cells form by telephone lesions in the mucosa lining of the anal canal (between the 1-800-263-1638 anus and the rectum). The lesions typically form inside the anal 416-203-7122 canal or just outside the anal opening. by fax 416-203-8284 Although there are over 100 different types of the human papillomavirus (HPV), anal dysplasia is usually caused by certain by e-mail strains of HPV which can be transmitted sexually. HPV can shut [email protected] off the proteins that help prevent dysplasia and cancer cells from developing, therefore leading to HPV-associated diseases by mail such as anal dysplasia. 555 Richmond Street West Suite 505, Box 1104 It is difficult to screen for anal dysplasia since the lesions are Toronto ON M5V 3B1 not detectable by routine examinations. As a result, anal dysplasia is often not detected until it has developed into anal cancer, which can be difficult to treat depending on the severity. Specific screening tests can detect dysplasia or precancerous changes. If these precancers are treated, anal cancer may be prevented. Anal cancer is usually treated with radiation and chemotherapy or with surgery. Although anal dysplasia may be treated successfully, individuals with HIV are at increased risk of it recurring and may need to be monitored closely by a trained physician. Consistent condom use reduces, but does not eliminate, the risk of transmitting HPV. -
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. -
Endoscopy Matrix
Endoscopy Matrix CPT Description of Endoscopy Diagnostic Therapeutic Code (Surgical) 31231 Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure) X 31233 Nasal/sinus endoscopy, diagnostic with maxillary sinusoscopy (via X inferior meatus or canine fossa puncture) 31235 Nasal/sinus endoscopy, diagnostic with sphenoid sinusoscopy (via X puncture of sphenoidal face or cannulation of ostium) 31237 Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or X debridement (separate procedure) 31238 Nasal/sinus endoscopy, surgical; with control of hemorrhage X 31239 Nasal/sinus endoscopy, surgical; with dacryocystorhinostomy X 31240 Nasal/sinus endoscopy, surgical; with concha bullosa resection X 31241 Nasal/sinus endoscopy, surgical; with ligation of sphenopalatine artery X 31253 Nasal/sinus endoscopy, surgical; with ethmoidectomy, total (anterior X and posterior), including frontal sinus exploration, with removal of tissue from frontal sinus, when performed 31254 Nasal/sinus endoscopy, surgical; with ethmoidectomy, partial (anterior) X 31255 Nasal/sinus endoscopy, surgical; with ethmoidectomy, total (anterior X and posterior 31256 Nasal/sinus endoscopy, surgical; with maxillary antrostomy X 31257 Nasal/sinus endoscopy, surgical; with ethmoidectomy, total (anterior X and posterior), including sphenoidotomy 31259 Nasal/sinus endoscopy, surgical; with ethmoidectomy, total (anterior X and posterior), including sphenoidotomy, with removal of tissue from the sphenoid sinus 31267 Nasal/sinus endoscopy, surgical; with removal of -
Public Use Data File Documentation
Public Use Data File Documentation Part III - Medical Coding Manual and Short Index National Health Interview Survey, 1995 From the CENTERSFOR DISEASECONTROL AND PREVENTION/NationalCenter for Health Statistics U.S. DEPARTMENTOF HEALTHAND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Health Statistics CDCCENTERS FOR DlSEASE CONTROL AND PREVENTlON Public Use Data File Documentation Part Ill - Medical Coding Manual and Short Index National Health Interview Survey, 1995 U.S. DEPARTMENT OF HEALTHAND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Health Statistics Hyattsville, Maryland October 1997 TABLE OF CONTENTS Page SECTION I. INTRODUCTION AND ORIENTATION GUIDES A. Brief Description of the Health Interview Survey ............. .............. 1 B. Importance of the Medical Coding ...................... .............. 1 C. Codes Used (described briefly) ......................... .............. 2 D. Appendix III ...................................... .............. 2 E, The Short Index .................................... .............. 2 F. Abbreviations and References ......................... .............. 3 G. Training Preliminary to Coding ......................... .............. 4 SECTION II. CLASSES OF CHRONIC AND ACUTE CONDITIONS A. General Rules ................................................... 6 B. When to Assign “1” (Chronic) ........................................ 6 C. Selected Conditions Coded ” 1” Regardless of Onset ......................... 7 D. When to Assign -
Provider Bulletin Prior Authorization Requirement for Gastrointestinal
Medicaid Managed Care Florida Healthy Kids Provider Bulletin August 2020 Prior authorization requirement for gastrointestinal codes done in the outpatient hospital setting (place of service 22) This communication applies to the Medicaid programs for Simply Healthcare Plans, Inc. and Clear Health Alliance as well as the Florida Healthy Kids program for Simply. Prior authorization requirements Effective October 1, 2020, prior authorization (PA) requirements will be required for the below CPT® codes if requested in the outpatient (OP) hospital setting. Prior authorization will be required for place of service 22 (OP hospital) only. No authorization will be required if done in an alternate OP place of service, such as an ancillary surgery center. For services that are scheduled on or after October 1, 2020, providers must contact Simply and CHA to obtain prior authorization for these services requested in the hospital. Providers are strongly encouraged to verify that a prior authorization has been obtained before scheduling and performing services in the outpatient hospital. To request PA, you may use one of the following methods: Web: https://www.availity.com* Fax: 1-866-495-1981 43200 ESOPHAGOSCOPY FLEXIBLE TRANSORAL DIAGNOSTIC 44382 ILEOSCOPY STOMA W/BX SINGLE/MULTIPLE 43202 ESOPHAGOSCOPY FLEXIBLE TRANSORAL WITH BIOPSY 44388 COLONOSCOPY STOMA DX INCLUDING COLLJ SPEC SPX 43215 ESOPHAGOSCOPY FLEXIBLE REMOVAL FOREIGN BODY 45308 PROCTOSGMDSC RIGID RMVL 1 LESION CAUTERY 43220 ESOPHAGOSCOPY FLEX BALLOON DILAT <30 MM DIAM 45330 SIGMOIDOSCOPY -
Molecular Basis for Therapy of AIDS-Defining Cancers
Molecular Basis for Therapy of AIDS-Defining Cancers Dirk P. Dittmer · Susan E. Krown Editors Molecular Basis for Therapy of AIDS-Defining Cancers 123 Editors Dirk P. Dittmer Susan E. Krown Associate Professor Member Department of Microbiology Melanoma and Sarcoma Service and Immunology Division of Solid Tumor Oncology Department of Medicine Lineberger Comprehensive Memorial Sloan-Kettering Cancer Center Cancer Center Center for AIDS Research 1275 York Avenue 715 Mary Ellen Jones, CB 7290 New York, NY 10065 University of North Carolina Professor of Medicine at Chapel Hill Weill Cornell Medical College Chapel Hill, NC 27599-7290 New York, NY [email protected] [email protected] ISBN 978-1-4419-1512-2 e-ISBN 978-1-4419-1513-9 DOI 10.1007/978-1-4419-1513-9 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2010926491 © Springer Science+Business Media, LLC 2010 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights.