A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer

Frontiers in Endocrinology

John J. Matelski¹  Shamir P. Chandarana²  Jennifer Jones²  Eitan Prisman³  Maryse Brassard⁴  Lorne Rotstein⁵  Dale Brown⁶  Han Zhang⁷  John de Almeida⁸  Anthony C. Nichols⁹  Michael Gupta⁹  Deric Morrison^1,10  Stephanie Johnson-Obeski^1,11  Sana Ghaznavi^1,12  Don Anderson^1,12  Amiram Gafni^1,13  Wei Xu^1,14  David P. Goldstein^1,15  the Canadian Thyroid Cancer Active Surveillance Study Group^1,16  James P. Brierley^1,17  Richard W. Tsang^1,17  Kareem Nazarali^1,17  Michael Chang^1,17  Laura Whiteacre^1,17  Mark Korman^1,17  Shereen Ezzat^1,17  Danny Enepekides^1,17  Sumeet Anand^1,17  Everton Gooden^1,17  Vinay Fernandes^1,17  Karen Devon^1,17  Eric Arruda^1,17  Maky Hafidh^1,17  Kevin Higgins^1,17  Jacqueline Jame^1,17  Denny Lin^1,17  Manish Shah^1,17  Artur Gevorgyan^1,17  Patrick Gullane^1,17  Karen Gomez Hernandez^1,17  Ilana J. Halperin^1,17  Jesse Pasterna^1,17  Douglas Chepeha^1,17  Afshan Zahedi^1,17  Raewyn Seaburg^1,17  Janet Chung^1,17  Vinod Bharadwaj^1,17  Jonathan Irish^1,17  Ralph Gilbert^1,17  Eric Monteiro^1,17  Antoine Eskander^1,17  Vinita Bindlish^1,17  Avik Banerjee^1,17  George Tomlinson^1,18  Martin Corsten^1,19  Nathalie Audet^2,20  Eric Bissada^2,21  Syed Ali Imran^2,22  Anna M. Sawka^2,23  Rebecca Lebouef^2,24  Sangeet Ghai^2,25  Nancy N. Baxter^2,26 

[1] Neck Surgery, Department of Surgery, University of Calgary, Calgary, AB, Canada;Neck Surgery, University of British Columbia, Vancouver, BC, Canada;Neck Surgery, University of Ottawa, Ottawa, ON, Canada;0Division of Endocrinology, Department of Medicine, Université Laval, Quebec City, QC, Canada;0Mount Sinai Hospital, University of Toronto, Toronto, Biostatistics Research Unit, University Health Network, Toronto, ON, Canada;1Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada;1Department of Otolaryngology-Head and Neck Surgery, McMaster University, Hamilton, ON, Canada;2Department of Otolaryngology and Head and Neck Surgery, University Health Network and University of Toronto, Toronto, ON, Canada;2Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada;3Division of Endocrinology, Department of Medicine, Western University, London, ON, Canada;;4Department of Otolaryngology-Head &;5Department of Otolaryngology-Head &;6Section of Otolaryngology-Head &7Division of Endocrinology, Department of Medicine, University of Calgary, Calgary, AB, Canada;8Department of Psychosocial Oncology, University Health Network and University of Toronto, Toronto, ON, Canada;9Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, ON, Canada;;Department of Medicine, University Health Network and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada;Department of Otolaryngology-Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada;Department of Otolaryngology-Head and Neck Surgery, Université Laval, Quebec City, QC, Canada;Department of Otolaryngology-Head and Neck Surgery, l’Université de Montréal, Montreal, QC, Canada;Division of Endocrinology, Department of Medicine, Dalhousie University, Halifax, NS, Canada;Division of Endocrinology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada;Division of Endocrinology, Department of Medicine, l’Université de Montréal, Montreal, QC, Canada;Joint Department of Medical Imaging, University Health Network-Mt Sinai Hospital-Women’s College Hospital, University of Toronto, Toronto, ON, Canada;Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia;

关键词: papillary thyroid cancer;    papillary thyroid microcarcinoma;    active surveillance;    thyroidectomy;    observational cohort study;    prospective research;   

DOI  :  10.3389/fendo.2021.686996

来源: DOAJ

【 摘 要 】

BackgroundThe traditional management of papillary thyroid cancer (PTC) is thyroidectomy (total or partial removal of the thyroid). Active surveillance (AS) may be considered as an alternative option for small, low risk PTC. AS involves close follow-up (including regularly scheduled clinical and radiological assessments), with the intention of intervening with surgery for disease progression or patient preference.MethodsThis is a protocol for a prospective, observational, long-term follow-up multi-centre Canadian cohort study. Consenting eligible adults with small, low risk PTC (< 2cm in maximal diameter, confined to the thyroid, and not immediately adjacent to critical structures in the neck) are offered the choice of AS or surgery for management of PTC. Patient participants are free to choose either option (AS or surgery) and the disease management course is thus not assigned by the investigators. Surgery is provided as usual care by a surgeon in an institution of the patient’s choice. Our primary objective is to determine the rate of ‘failure’ of disease management in respective AS and surgical arms as defined by: i) AS arm – surgery for progression of PTC, and ii) surgical arm - surgery or other treatment for disease persistence or progression after completing initial treatment. Secondary outcomes include long-term thyroid oncologic and treatment outcomes, as well as patient-reported outcomes.DiscussionThe results from this study will provide long-term clinical and patient reported outcome evidence regarding active surveillance or immediate surgery for management of small, low risk PTC. This will inform future clinical trials in disease management of small, low risk papillary thyroid cancer.Registration detailsThis prospective observational cohort study is registered on clinicaltrials.gov (NCT04624477), but it should not be considered a clinical trial as there is no assigned intervention and patients are free to choose either AS or surgery.

【 授权许可】

Unknown