Clinical trial · Observational

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

Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer

NCT03271892CI-TRIAL-00098019AS-PTCactive not recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a prospective observational study. 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. 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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Thyroid Cancer Stage I	Malignant Thyroid Gland Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
Active surveillance
description
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.
label
Immediate Surgery
description
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.

Primary outcomes (2)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 100 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

1. Regional or distant metastatic thyroid cancer
2. History of prior thyroid cancer surgery
3. High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
4. 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)
5. Known or suspected poorly differentiated or non-papillary thyroid cancer
6. Medically unfit for surgery due to co-morbidity
7. Another active malignancy with limited life expectancy of \< 1 year.
8. Pregnancy at the time of study enrollment.
9. Other absolute indication for thyroid or parathyroid surgery
10. 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.

References

Publications (7)

BACKGROUNDSawka 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
BACKGROUNDSawka 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
BACKGROUNDSawka 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
BACKGROUNDSawka 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
BACKGROUNDSawka 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

Registry

Dates and enrollment

Start: May 11, 2016
Primary completion: Dec 31, 2031
Completion: Dec 31, 2031
First posted: Sep 5, 2017
Last update posted: Nov 26, 2025
Enrollment: 200 (estimated)
Lead sponsor: University Health Network, Toronto OTHER
Collaborators: Canadian Cancer Society (CCS); Ontario Ministry of Health and Long Term Care; Canadian Institutes of Health Research (CIHR)
Keywords: papillary thyroid cancer, thyroidectomy, active surveillance

Data updated 22 days agoSource updated Nov 26, 2025source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Canada	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.