A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer
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 radi...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-06-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fendo.2021.686996/full |
| _version_ | 1818664438022012928 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Anna M. Sawka |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T05:32:44Z |
| format | Article |
| id | doaj.art-c3cd6772974e4fb88d49087c38c0732c |
| institution | Directory Open Access Journal |
| issn | 1664-2392 |
| language | English |
| last_indexed | 2024-12-17T05:32:44Z |
| publishDate | 2021-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Endocrinology |
| spelling | doaj.art-c3cd6772974e4fb88d49087c38c0732c2022-12-21T22:01:41ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922021-06-011210.3389/fendo.2021.686996686996A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid CancerAnna M. Sawka0Sangeet Ghai1George Tomlinson2Nancy N. Baxter3Martin Corsten4Syed Ali Imran5Eric Bissada6Rebecca Lebouef7Nathalie Audet8Maryse Brassard9Han Zhang10Michael Gupta11Anthony C. Nichols12Deric Morrison13Stephanie Johnson-Obeski14Eitan Prisman15Don Anderson16Shamir P. Chandarana17Sana Ghaznavi18Jennifer Jones19Amiram Gafni20John J. Matelski21Wei Xu22David P. Goldstein23the Canadian Thyroid Cancer Active Surveillance Study GroupLorne RotsteinDale BrownJohn de AlmeidaPatrick GullaneRalph GilbertDouglas ChepehaJonathan IrishJesse PasternaShereen EzzatJames P. BrierleyRichard W. TsangEric MonteiroAfshan ZahediJacqueline JameKaren Gomez HernandezAntoine EskanderDanny EnepekidesKevin HigginsIlana J. HalperinAfshan ZahediKaren DevonEverton GoodenManish ShahMark KormanJanet ChungKareem NazaraliEric ArrudaArtur GevorgyanMichael ChangSumeet AnandVinay FernandesDenny LinAvik BanerjeeVinita BindlishVinod BharadwajMaky HafidhRaewyn SeaburgLaura WhiteacreDivision of Endocrinology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, CanadaJoint Department of Medical Imaging, University Health Network-Mt Sinai Hospital-Women’s College Hospital, University of Toronto, Toronto, ON, CanadaDepartment of Medicine, University Health Network and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, CanadaMelbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, AustraliaDepartment of Otolaryngology-Head and Neck Surgery, Dalhousie University, Halifax, NS, CanadaDivision of Endocrinology, Department of Medicine, Dalhousie University, Halifax, NS, CanadaDepartment of Otolaryngology-Head and Neck Surgery, l’Université de Montréal, Montreal, QC, CanadaDivision of Endocrinology, Department of Medicine, l’Université de Montréal, Montreal, QC, CanadaDepartment of Otolaryngology-Head and Neck Surgery, Université Laval, Quebec City, QC, Canada0Division of Endocrinology, Department of Medicine, Université Laval, Quebec City, QC, Canada1Department of Otolaryngology-Head and Neck Surgery, McMaster University, Hamilton, ON, Canada2Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada2Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada3Division of Endocrinology, Department of Medicine, Western University, London, ON, Canada4Department of Otolaryngology-Head & Neck Surgery, University of Ottawa, Ottawa, ON, Canada5Department of Otolaryngology-Head & Neck Surgery, University of British Columbia, Vancouver, BC, Canada5Department of Otolaryngology-Head & Neck Surgery, University of British Columbia, Vancouver, BC, Canada6Section of Otolaryngology-Head & Neck Surgery, Department of Surgery, University of Calgary, Calgary, AB, Canada7Division of Endocrinology, Department of Medicine, University of Calgary, Calgary, AB, Canada8Department of Psychosocial Oncology, University Health Network and University of Toronto, Toronto, ON, Canada9Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, ON, Canada0Mount Sinai Hospital, University of Toronto, Toronto, Biostatistics Research Unit, University Health Network, Toronto, ON, Canada1Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada2Department of Otolaryngology and Head and Neck Surgery, University Health Network and University of Toronto, Toronto, ON, CanadaBackgroundThe 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.https://www.frontiersin.org/articles/10.3389/fendo.2021.686996/fullpapillary thyroid cancerpapillary thyroid microcarcinomaactive surveillancethyroidectomyobservational cohort studyprospective research |
| spellingShingle | 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 A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer Frontiers in Endocrinology papillary thyroid cancer papillary thyroid microcarcinoma active surveillance thyroidectomy observational cohort study prospective research |
| title | A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer |
| title_full | A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer |
| title_fullStr | A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer |
| title_full_unstemmed | A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer |
| title_short | A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer |
| title_sort | protocol for a pan canadian prospective observational study on active surveillance or surgery for very low risk papillary thyroid cancer |
| topic | papillary thyroid cancer papillary thyroid microcarcinoma active surveillance thyroidectomy observational cohort study prospective research |
| url | https://www.frontiersin.org/articles/10.3389/fendo.2021.686996/full |
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protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer AT avikbanerjee protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer AT vinitabindlish protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer AT vinodbharadwaj protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer AT makyhafidh protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer AT raewynseaburg protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer AT laurawhiteacre protocolforapancanadianprospectiveobservationalstudyonactivesurveillanceorsurgeryforverylowriskpapillarythyroidcancer |