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

NCT03271892 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-11-26

No results posted yet for this study

Summary

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

  • Thyroid Cancer Stage I

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Anna M Sawka, MD,PhD · University Health Network, Toronto

  • David P Goldstein, MD, PhD · University Health Network, Toronto

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03271892 on ClinicalTrials.gov