{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T19:07:00Z","timestamp":1790968020302,"version":"4.1.0"},"reference-count":45,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"8","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Global Oncology"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> This ongoing trial is comparing the efficacy and safety of three ablation treatments for cervical intraepithelial neoplasia grade 2 or higher. Here, we present early data regarding pain, side effects, and acceptability of CO<jats:sub>2<\/jats:sub> gas-based cryotherapy (CO<jats:sub>2<\/jats:sub>), nongas cryotherapy, and thermal ablation (TA). Efficacy results are expected to become available in late 2023. <\/jats:p><\/jats:sec><jats:sec><jats:title>MATERIALS AND METHODS<\/jats:title><jats:p> This noninferiority randomized trial is taking place in El Salvador, China, and Colombia. Patients are 1,152 eligible women with biopsy-confirmed cervical intraepithelial neoplasia grade 2 or higher who will receive one of three ablation treatments. Pain is measured before, during, and after treatment with a visual analog scale (1-10). Side effects and acceptability are assessed at 6 weeks. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> To date, 1,024 of 1,152 (89%) women were randomly assigned to treatment. The median pain level was higher during TA (4, IQR = 4) than CO<jats:sub>2<\/jats:sub> (2, IQR = 4) or nongas cryotherapy (2, IQR = 4) ( P &lt; .01, range: 0-10). The most common post-treatment symptom was watery discharge, reported by 97.9% of women, and it lasted longer in the CO<jats:sub>2<\/jats:sub> group than the other two treatments (in days, median [IQR]: CO<jats:sub>2<\/jats:sub> = 20[20], nongas cryotherapy = 15[10], TA = 18[15], P &lt; .01). Bleeding was reported more frequently in women treated with TA (27.6%) than CO<jats:sub>2<\/jats:sub> (17.5) or nongas cryotherapy (18.7%) ( P &lt; .01). The majority of patients reported being very satisfied with the treatment they received at 6 weeks (91%) and again at 12 months post-treatment (97%). <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Despite differences in pain and side effects across ablation treatments, all were safe and highly acceptable to patients. In addition to efficacy, considerations such as cost and portability may be more significant in choosing a treatment method. <\/jats:p><\/jats:sec>","DOI":"10.1200\/go.22.00112","type":"journal-article","created":{"date-parts":[[2022,12,16]],"date-time":"2022-12-16T20:59:41Z","timestamp":1671224381000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":6,"title":["Safety and Acceptability of Three Ablation Treatments for High-Grade Cervical Precancer: Early Data From a Randomized Noninferiority Clinical Trial"],"prefix":"10.1200","clinical-trial-number":[{"clinical-trial-number":"nct03084081","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1193-8710","authenticated-orcid":false,"given":"Montserrat","family":"Soler","sequence":"first","affiliation":[{"name":"Ob\/Gyn and Women's Health Institute, Cleveland Clinic, Cleveland, OH"},{"name":"Basic Health International, Pittsburgh, PA; San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karla","family":"Alfaro","sequence":"additional","affiliation":[{"name":"Basic Health International, Pittsburgh, PA; San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3761-858X","authenticated-orcid":false,"given":"Rachel J.","family":"Masch","sequence":"additional","affiliation":[{"name":"Basic Health International, Pittsburgh, PA; San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel","family":"Conzuelo Rodriguez","sequence":"additional","affiliation":[{"name":"Basic Health International, Pittsburgh, PA; San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinfeng","family":"Qu","sequence":"additional","affiliation":[{"name":"Basic Health International, Pittsburgh, PA; San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suhui","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingfen","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dayana Marinela","family":"Hern\u00e1ndez Jovel","sequence":"additional","affiliation":[{"name":"Ginecolog\u00eda y Obstetricia, Hospital Primero de Mayo, Instituto Salvadore\u00f1o del Seguro Social, San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7030-477X","authenticated-orcid":false,"given":"Jairo","family":"Bonilla","sequence":"additional","affiliation":[{"name":"Centro Javeriano de Oncolog\u00eda, Hospital Universitario San Ignacio, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis Orlando","family":"Puentes","sequence":"additional","affiliation":[{"name":"Centro Javeriano de Oncolog\u00eda, Hospital Universitario San Ignacio, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7187-9946","authenticated-orcid":false,"given":"Ra\u00fal","family":"Murillo","sequence":"additional","affiliation":[{"name":"Centro Javeriano de Oncolog\u00eda, Hospital Universitario San Ignacio, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd A.","family":"Alonzo","sequence":"additional","affiliation":[{"name":"Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan C.","family":"Felix","sequence":"additional","affiliation":[{"name":"Department of Pathology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1082-6554","authenticated-orcid":false,"given":"Philip","family":"Castle","sequence":"additional","affiliation":[{"name":"Divisions of Cancer Prevention and Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Cremer","sequence":"additional","affiliation":[{"name":"Ob\/Gyn and Women's Health Institute, Cleveland Clinic, Cleveland, OH"},{"name":"Basic Health International, Pittsburgh, PA; San Salvador, El Salvador"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"b1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"b2","doi-asserted-by":"publisher","DOI":"10.3892\/ol.2020.11754"},{"key":"b3","volume-title":"WHO Director-General Calls for All Countries to Take Action to Help End the Suffering Caused by Cervical Cancer","author":"World Health Organization","year":"2018"},{"key":"b4","volume-title":"Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem","author":"Cervical Cancer Elimination Initiative","year":"2020"},{"key":"b5","volume-title":"WHO Guidelines for Screening and Treatment of Precancerous Lesions for Cervical Cancer Prevention","author":"World Health Organization","year":"2013"},{"key":"b6","volume-title":"WHO Guidelines for the Use of Thermal Ablation for Cervical Pre-Cancer Lesions","author":"Guidelines Review Committee","year":"2019"},{"key":"b7","first-page":"CD001318","volume":"12","author":"Martin-Hirsch PPL","year":"2013","journal-title":"Cochrane Database Syst Rev 2013"},{"key":"b8","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6603633"},{"key":"b9","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2012.10.014"},{"key":"b10","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-020484"},{"key":"b11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2008.07.016"},{"key":"b12","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.12185"},{"key":"b13","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.18-S2-6"},{"key":"b14","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0000000000000359"},{"key":"b15","doi-asserted-by":"publisher","DOI":"10.9745\/GHSP-D-16-00270"},{"key":"b16","doi-asserted-by":"publisher","DOI":"10.1136\/ijgc-2018-000148"},{"key":"b17","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.12655"},{"key":"b18","doi-asserted-by":"publisher","DOI":"10.1016\/j.ypmed.2018.10.006"},{"key":"b19","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.12191"},{"key":"b20","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30732-6"},{"key":"b21","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2012.01.029"},{"key":"b22","volume-title":"WHO Technical Specifications: Cryosurgical Equipment for the Treatment of Precancerous Cervical Lesions and Prevention of Cervical Cancer","author":"World Health Organization","year":"2012"},{"key":"b23","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2011.03.009"},{"key":"b24","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2014.10.032"},{"key":"b25","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2015.07.026"},{"key":"b26","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmwh.2005.04.004"},{"key":"b27","volume-title":"Cervical Cancer Prevention: Issues in Depth, EngenderHealth, IARC, JHPIEGO, PAHO, PATH","author":"Castro W","year":"2003"},{"key":"b28","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.30101"},{"key":"b29","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2015.09.035"},{"key":"b30","doi-asserted-by":"publisher","DOI":"10.14740\/jcgo464w"},{"key":"b31","doi-asserted-by":"publisher","DOI":"10.2147\/IJWH.S142911"},{"key":"b32","doi-asserted-by":"publisher","DOI":"10.1186\/s12905-016-0355-x"},{"key":"b33","doi-asserted-by":"publisher","DOI":"10.1186\/s12905-016-0304-8"},{"key":"b34","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.33549"},{"key":"b35","doi-asserted-by":"publisher","DOI":"10.1111\/tmi.13315"},{"key":"b36","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.32881"},{"key":"b37","doi-asserted-by":"publisher","DOI":"10.1111\/jog.14520"},{"key":"b38","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30635-7"},{"key":"b39","doi-asserted-by":"publisher","DOI":"10.1200\/GO.20.00035"},{"key":"b40","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103208"},{"key":"b41","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"b42","first-page":"8","volume":"33","author":"Wong DL","year":"1988","journal-title":"Okla Nurse"},{"key":"b43","doi-asserted-by":"publisher","DOI":"10.1109\/JTEHM.2017.2761764"},{"key":"b44","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-049901"},{"key":"b45","volume-title":"Key Facts and Latest Estimates on the Global HIV Epidemic, Geneva, Switzerland, World Health Organization","author":"World Health Organization","year":"2020"}],"container-title":["JCO Global Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/GO.22.00112","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,16]],"date-time":"2022-12-16T21:00:03Z","timestamp":1671224403000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/GO.22.00112"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12]]},"references-count":45,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1200\/GO.22.00112"],"URL":"https:\/\/doi.org\/10.1200\/go.22.00112","relation":{},"ISSN":["2687-8941"],"issn-type":[{"value":"2687-8941","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12]]},"assertion":[{"value":"2022-03-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-12","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-01","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-12-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e2200112"}}