Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer

NCT03271892 | Active Not Recruiting

• 1 other identifier: 15-8942
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational study.

1. 1.In the first part of the study, consenting eligible adult patients with low risk papillary thyroid cancer that is confined to the thyroid, are provided verbal and written information about their disease and the option of active surveillance (close monitoring with intention to treat if disease progresses or if the patient changes her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional standard of care). Patients are free to make their own disease management choice (ie. active surveillance or thyroidectomy) and the investigators are examining how often patients choose each of these options. The investigators are also examining the reasons for their choice.
2. 2.In the second part of the study, consenting, eligible patients who completed the preceding part of the study and chose either a) active surveillance, or b) thyroid surgery, are tracked with respect to clinical and psychosocial outcomes as well as quality of life. Patients who chose active surveillance are free to change their mind and have surgery at any point, even if the disease does not progress. The primary study outcome is decision regret at one year, in the respective groups of patients who chose active surveillance or thyroidectomy.

Conditions

Thyroid Cancer Stage I

Keywords

papillary thyroid cancer; thyroidectomy; active surveillance

Outcome Measures

Primary Outcomes (2)

• Disease management decision (first part of the study, focused on treatment management choice)

  In the first part of the study, at any time point after study enrollment and receiving written and verbal information about disease prognosis and the option of active surveillance, patients will be asked to provide a final disease management decision (active surveillance or surgery). This decision should be generally finalized within 3 months of enrollment in the study.

  0 to 3 months after enrollment in the study (as it is expected that the disease management decision should be completed within that time frame)

• Decision regret (second part of the study - follow-up of respective active surveillance and surgical patient groups)

  Decision regret (total score, self-administered written questionnaire)

  1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)

Secondary Outcomes (17)

• Disease management decision rationale/explanation

  0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)

• Disease management decision-maker identification

  0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)

• Disease management decision satisfaction

  0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)

• Baseline coping mechanisms in all patients and respective study groups

  Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)

• Baseline evaluation of fear of disease progression in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)

  Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)

Study Arms (2)

Active surveillance

Patients under active surveillance choose to not have immediate thyroidectomy. Patients are closely monitored with respect to clinical status, ultrasound imaging, biochemical indices (thyroid function, thyroglobulin, and thyroglobulin antibodies) and any thyroid cancer-related treatments (if needed). Active surveillance is conducted at a participating study site. Criteria defining disease progression are established, and if such criteria are met, thyroid surgery is recommended to the patient. However, patients are free to choose to have thyroid surgery at any time, in the absence of disease progression. Thyroid cancer clinical and treatment outcomes are tracked by the study team.

Immediate Surgery

Patients who choose surgery, undergo thyroidectomy, as per current standards of care, by a surgeon of their choice in an institution of their choice. The treating surgeon, in discussion with the patient, will choose the extent of thyroid surgery that may be appropriate for the individual case. Post-surgical follow-up is per the discretion of the treating surgeon, endocrinologist, or other healthcare providers involved in the patient's thyroid cancer care. Thyroid cancer clinical and treatment outcomes are tracked by the study team.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting individuals aged 18 years of age or older with papillary thyroid cancer (PTC) who have a primary tumor that is \<2cm in maximal diameter, and fine needle aspiration biopsy is positive or suspicious for PTC. The tumor must be confined to the thyroid (no metastatic disease) and not considered in a high risk location (e.g. adjacent to the recurrent laryngeal nerve or trachea). The patient must have no prior surgical treatment for thyroid cancer.

You may qualify if:

• Patients 18 years of age or older
• Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC).
• PTC must be less than 2 cm in maximal diameter on thyroid ultrasound
• No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer.
• No other absolute indications for thyroid or parathyroid surgery
• Permission for review of thyroid cancer-related medical records

You may not qualify if:

• Regional or distant metastatic thyroid cancer
• History of prior thyroid cancer surgery
• High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
• The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus)
• Known or suspected poorly differentiated or non-papillary thyroid cancer
• Medically unfit for surgery due to co-morbidity
• Another active malignancy with limited life expectancy of \< 1 year.
• Pregnancy at the time of study enrollment.
• Other absolute indication for thyroid or parathyroid surgery
• Unable to provide informed consent for the study or comply with study follow-up procedures due to current severe active cognitive or psychiatric impairment, substance abuse, or other reasons.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Cancer Society (CCS): collaborator
• Ontario Ministry of Health and Long Term Care: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (7)

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Su J, Xu W, Esemezie AO, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Long-Term Durability of Active Surveillance of Small, Low-Risk Papillary Thyroid Cancer. JAMA Surg. 2025 Oct 1;160(10):1117-1124. doi: 10.1001/jamasurg.2025.2957.

  PMID: 40833769 BACKGROUND

• Sawka AM, Ghai S, Tomlinson G, Rotstein L, Gilbert R, Gullane P, Pasternak J, Brown D, de Almeida J, Irish J, Chepeha D, Higgins K, Monteiro E, Jones JM, Gafni A, Goldstein DP. A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer. BMJ Open. 2018 Apr 12;8(4):e020298. doi: 10.1136/bmjopen-2017-020298.

  PMID: 29654030 BACKGROUND

• Sawka AM, Ghai S, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP, On Behalf Of The Canadian Thyroid Cancer Active Surveillance Study Group. Decision-making in Surgery or Active Surveillance for Low Risk Papillary Thyroid Cancer During the COVID-19 Pandemic. Cancers (Basel). 2021 Jan 20;13(3):371. doi: 10.3390/cancers13030371.

  PMID: 33498497 BACKGROUND

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Gooden E, Brown DH, Eskander A, Zahedi A, Chung J, Su J, Xu W, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Active Surveillance Study Group (Greater Toronto Area). A Quantitative Analysis Examining Patients' Choice of Active Surveillance or Surgery for Managing Low-Risk Papillary Thyroid Cancer. Thyroid. 2022 Mar;32(3):255-262. doi: 10.1089/thy.2021.0485. Epub 2022 Feb 17.

  PMID: 35019770 BACKGROUND

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Zahedi A, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP. Decision Regret Following the Choice of Surgery or Active Surveillance for Small, Low-Risk Papillary Thyroid Cancer: A Prospective Cohort Study. Thyroid. 2024 May;34(5):626-634. doi: 10.1089/thy.2023.0634. Epub 2024 Apr 8.

  PMID: 38481111 BACKGROUND

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Zahedi A, Gooden E, Eskander A, Chung J, Devon K, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Gender Differences in Fears Related to Low-Risk Papillary Thyroid Cancer and Its Treatment. JAMA Otolaryngol Head Neck Surg. 2023 Sep 1;149(9):803-810. doi: 10.1001/jamaoto.2023.1642.

  PMID: 37410454 BACKGROUND

• Sawka AM, Ghai S, Yoannidis T, Rotstein L, Gullane PJ, Gilbert RW, Pasternak JD, Brown DH, Eskander A, Almeida JR, Irish JC, Higgins K, Enepekides DJ, Monteiro E, Banerjee A, Shah M, Gooden E, Zahedi A, Korman M, Ezzat S, Jones JM, Rac VE, Tomlinson G, Stanimirovic A, Gafni A, Baxter NN, Goldstein DP. A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer. Thyroid. 2020 Jul;30(7):999-1007. doi: 10.1089/thy.2019.0592. Epub 2020 Apr 8.

  PMID: 32126932 BACKGROUND

Related Links

• Protocol manuscript - PMID: 29654030
• Study website

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Anna M Sawka, MD,PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• David P Goldstein, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 5, 2017
• Study Start: May 11, 2016
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CA (1)