Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer

Last updated: April 28, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Thyroid Disorders

Carcinoma

Treatment

N/A

Clinical Study ID

NCT04624477
20-5102
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, observational, multi-center study examining the long-term outcomes of patients with small, low risk papillary thyroid cancer who offered the choice of active surveillance (close follow-up to monitor for potential disease progression) or immediate surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years of age or older.

  • Newly diagnosed previously surgically untreated papillary thyroid cancer (PTC) orsuspicious for PTC on fine needle aspiration biopsy of the thyroid. PTC must be < 2cm in maximal diameter on thyroid ultrasound.

  • The absence of metastatic cervical lymphadenopathy or gross extrathyroidal extensionof PTC, as confirmed on neck ultrasound imaging.

  • The absence of other current absolute indication for thyroid or parathyroid surgery (e.g. severe hyperthyroidism that cannot be controlled medically, large goitre withsevere compressive symptoms, or primary hyperthyroidism meeting surgical criteria).

Exclusion

Exclusion Criteria:

  • Metastatic thyroid cancer (lymph nodes or distant).

  • History of prior thyroid surgery for any indication.

  • The primary PTC being on the trachea or immediately adjacent to the recurrentlaryngeal nerve, and with progression would be deemed to be at high risk of growthinto these critical structures.

  • Clinical signs, imaging, or laryngoscopy findings suggestive of locally advancedthyroid cancer (i.e. vocal cord paralysis due to the thyroid cancer or any clinicalor radiographic signs of extrathyroidal invasion into adjacent structures such asthe strap muscles of the neck, trachea or esophagus).

  • Known/suspected poorly differentiated or non-papillary thyroid cancer.

  • Medically unfit for surgery due to severe co-morbidity. Severe comorbidity mayinclude another active malignancy with limited life expectancy of < 1 year).

  • Pregnancy at the time of study enrollment.

  • Unable/unwilling to provide informed consent for the study or comply with studyfollow-up procedures due to current active physical limitations/medicalco-morbidity, cognitive, or psychiatric impairment substance abuse, or otherreasons.

Study Design

Total Participants: 450
Study Start date:
February 03, 2021
Estimated Completion Date:
December 31, 2034

Study Description

This is a prospective, observational multi-center study, building on an initial single-centre study from Toronto, Canada (ClinicalTrials.gov Identifier: NCT03271892). Adult patients with small, low-risk papillary thyroid cancer may choose either active surveillance (close follow-up with the intention of surgery if the disease progresses or if the patient changes their mind and wants surgery) or immediate thyroid surgery (thyroidectomy). Patients who choose active surveillance are clinically followed at the participating study centre and those who choose surgery, receive usual care from their treating surgeon and/or other thyroid cancer specialists.

Thyroid cancer clinical and treatment outcomes are tracked (by medical record review) at least yearly for up to 10 years after enrollment. Patients are also asked to complete study questionnaires (patient reported outcomes) yearly for up to 5 years.

The underlying assumption in the study is that since patients' disease management goals differ for individuals choosing active surveillance and those choosing surgery, 'successful' disease management is defined differently for these patient groups. For patients choosing active surveillance, successful disease management may be defined by avoiding thyroid surgery for thyroid cancer progression (i.e. thyroid cancer that has grown or spread to other tissues). For patients choosing surgery, the ultimate goal is cure of the thyroid cancer (i.e. no thyroid cancer detected at long-term follow-up).

The primary analysis in this study is a description of how often patients' initial disease management goals are not achieved at long-term follow-up. For this study, 'failure' of disease management is defined as follows: a) in active surveillance group - surgery for disease progression, and b) in the immediate surgery group - requiring additional treatment for persistent or recurrent thyroid cancer (i.e. thyroid cancer that is detected and treated in follow-up). Thyroid cancer clinical and treatment outcomes as well as patient questionnaire outcomes will be reported.

Connect with a study center

  • University of Calgary, Cumming School of Medicine

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • University of British Columbia

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Nova Scotia Health

    Halifax, Nova Scotia B3H1V8
    Canada

    Site Not Available

  • St. Joseph's Healthcare

    Hamilton, Ontario
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6C2R5
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Division chirurgie ORL et cervico-faciale

    Montreal, Quebec
    Canada

    Site Not Available

  • CHU de Québec - Université Laval

    Québec, Quebec G1V 4G2
    Canada

    Site Not Available

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