Frontiers in Endocrinology (Jun 2021)
A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer
- Anna M. Sawka,
- Sangeet Ghai,
- George Tomlinson,
- Nancy N. Baxter,
- Martin Corsten,
- Syed Ali Imran,
- Eric Bissada,
- Rebecca Lebouef,
- Nathalie Audet,
- Maryse Brassard,
- Han Zhang,
- Michael Gupta,
- Anthony C. Nichols,
- Deric Morrison,
- Stephanie Johnson-Obeski,
- Eitan Prisman,
- Don Anderson,
- Shamir P. Chandarana,
- Sana Ghaznavi,
- Jennifer Jones,
- Amiram Gafni,
- John J. Matelski,
- Wei Xu,
- David P. Goldstein,
- the Canadian Thyroid Cancer Active Surveillance Study Group,
- Lorne Rotstein,
- Dale Brown,
- John de Almeida,
- Patrick Gullane,
- Ralph Gilbert,
- Douglas Chepeha,
- Jonathan Irish,
- Jesse Pasterna,
- Shereen Ezzat,
- James P. Brierley,
- Richard W. Tsang,
- Eric Monteiro,
- Afshan Zahedi,
- Jacqueline Jame,
- Karen Gomez Hernandez,
- Antoine Eskander,
- Danny Enepekides,
- Kevin Higgins,
- Ilana J. Halperin,
- Afshan Zahedi,
- Karen Devon,
- Everton Gooden,
- Manish Shah,
- Mark Korman,
- Janet Chung,
- Kareem Nazarali,
- Eric Arruda,
- Artur Gevorgyan,
- Michael Chang,
- Sumeet Anand,
- Vinay Fernandes,
- Denny Lin,
- Avik Banerjee,
- Vinita Bindlish,
- Vinod Bharadwaj,
- Maky Hafidh,
- Raewyn Seaburg,
- Laura Whiteacre
Affiliations
- Anna M. Sawka
- Division of Endocrinology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada
- Sangeet Ghai
- Joint Department of Medical Imaging, University Health Network-Mt Sinai Hospital-Women’s College Hospital, University of Toronto, Toronto, ON, Canada
- George Tomlinson
- Department of Medicine, University Health Network and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
- Nancy N. Baxter
- Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia
- Martin Corsten
- Department of Otolaryngology-Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada
- Syed Ali Imran
- Division of Endocrinology, Department of Medicine, Dalhousie University, Halifax, NS, Canada
- Eric Bissada
- Department of Otolaryngology-Head and Neck Surgery, l’Université de Montréal, Montreal, QC, Canada
- Rebecca Lebouef
- Division of Endocrinology, Department of Medicine, l’Université de Montréal, Montreal, QC, Canada
- Nathalie Audet
- Department of Otolaryngology-Head and Neck Surgery, Université Laval, Quebec City, QC, Canada
- Maryse Brassard
- 0Division of Endocrinology, Department of Medicine, Université Laval, Quebec City, QC, Canada
- Han Zhang
- 1Department of Otolaryngology-Head and Neck Surgery, McMaster University, Hamilton, ON, Canada
- Michael Gupta
- 2Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada
- Anthony C. Nichols
- 2Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada
- Deric Morrison
- 3Division of Endocrinology, Department of Medicine, Western University, London, ON, Canada
- Stephanie Johnson-Obeski
- 4Department of Otolaryngology-Head & Neck Surgery, University of Ottawa, Ottawa, ON, Canada
- Eitan Prisman
- 5Department of Otolaryngology-Head & Neck Surgery, University of British Columbia, Vancouver, BC, Canada
- Don Anderson
- 5Department of Otolaryngology-Head & Neck Surgery, University of British Columbia, Vancouver, BC, Canada
- Shamir P. Chandarana
- 6Section of Otolaryngology-Head & Neck Surgery, Department of Surgery, University of Calgary, Calgary, AB, Canada
- Sana Ghaznavi
- 7Division of Endocrinology, Department of Medicine, University of Calgary, Calgary, AB, Canada
- Jennifer Jones
- 8Department of Psychosocial Oncology, University Health Network and University of Toronto, Toronto, ON, Canada
- Amiram Gafni
- 9Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, ON, Canada
- John J. Matelski
- 0Mount Sinai Hospital, University of Toronto, Toronto, Biostatistics Research Unit, University Health Network, Toronto, ON, Canada
- Wei Xu
- 1Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
- David P. Goldstein
- 2Department of Otolaryngology and Head and Neck Surgery, University Health Network and University of Toronto, Toronto, ON, Canada
- the Canadian Thyroid Cancer Active Surveillance Study Group
- Lorne Rotstein
- Dale Brown
- John de Almeida
- Patrick Gullane
- Ralph Gilbert
- Douglas Chepeha
- Jonathan Irish
- Jesse Pasterna
- Shereen Ezzat
- James P. Brierley
- Richard W. Tsang
- Eric Monteiro
- Afshan Zahedi
- Jacqueline Jame
- Karen Gomez Hernandez
- Antoine Eskander
- Danny Enepekides
- Kevin Higgins
- Ilana J. Halperin
- Afshan Zahedi
- Karen Devon
- Everton Gooden
- Manish Shah
- Mark Korman
- Janet Chung
- Kareem Nazarali
- Eric Arruda
- Artur Gevorgyan
- Michael Chang
- Sumeet Anand
- Vinay Fernandes
- Denny Lin
- Avik Banerjee
- Vinita Bindlish
- Vinod Bharadwaj
- Maky Hafidh
- Raewyn Seaburg
- Laura Whiteacre
- DOI
- https://doi.org/10.3389/fendo.2021.686996
- Journal volume & issue
-
Vol. 12
Abstract
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.
Keywords
- papillary thyroid cancer
- papillary thyroid microcarcinoma
- active surveillance
- thyroidectomy
- observational cohort study
- prospective research