Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer

NCT04624477 | Active Not Recruiting DMC

• 1 other identifier: 20-5102
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Papillary Thyroid Cancer; Papillary Thyroid Carcinoma; Papillary Microcarcinoma of the Thyroid

Keywords

papillary thyroid cancer; papillary thyroid carcinoma; thyroid cancer; thyroid carcinoma; thyroid microcarcinoma; low risk thyroid cancer; active surveillance; thyroidectomy

Outcome Measures

Primary Outcomes (2)

• Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management

  'Failure' of Active Surveillance Disease Management is defined as: surgery for the indication of thyroid cancer that has progressed during study monitoring. Thyroid cancer disease progression under active surveillance includes: a) thyroid cancer enlargement \> 3mm in largest dimension, b) thyroid cancer growth in a location that is concerning (e.g. extension outside of the thyroid, concerning proximity to critical structures such as the trachea or recurrent laryngeal nerve), or c) development of metastatic disease (in lymph nodes or distant organs). The specific type of disease progression will be reported.

  Through study completion, an estimated average of 3 years

• Number of Participants in the Surgical Group who Experience 'Failure' of Surgical Disease Management

  For patients who choose immediate surgery for management of thyroid cancer, the intent of surgery is curative. Thus, 'failure' of surgical disease management is defined by receiving additional treatment for structural thyroid cancer detected at follow-up (i.e. treatment of thyroid cancer detected on imaging or biopsy during follow-up). Additional thyroid cancer treatment may include additional surgery, radioactive iodine, ethanol ablation of lymph nodes, or external beam radiation treatment. The specific treatment used for recurrent or persistent thyroid cancer and the indication for the treatment will be reported.

  Through study completion, an estimated average of 3 years

Secondary Outcomes (8)

• Number of Participants in Respective Thyroid Cancer Disease Status Categories at Last Follow-up

  Through study completion, an estimated average of 3 years

• Number of Participants in the Active Surveillance Group who Undergo Thyroidectomy During Follow-up

  Through study completion, an estimated average of 3 years

• Number of Participants who Experience Long-term Complications of Thyroid Surgery

  Through study completion, an estimated average of 3 years

• Description of Quality of Life (Thyroid Cancer-specific)

  Through study completion, an estimated average of 3 years

• Description of Quality of Life (Cancer-specific)

  Through study completion, an estimated average of 3 years

Study Arms (2)

Active Surveillance

Patients under active surveillance choose to not have immediate thyroid surgery. 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 received). 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 Thyroid Surgery (total or partial thyroidectomy)

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+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (aged 18 years of age or older) with small (\< 2cm maximal diameter) low risk papillary thyroid cancer that is confined to the thyroid (with no evidence of metastatic disease, no extrathyroidal extension, which is not in a location that is of high risk for invasion of the trachea or recurrent laryngeal nerve).

You may qualify if:

• Patients 18 years of age or older.
• Newly diagnosed previously surgically untreated papillary thyroid cancer (PTC) or suspicious for PTC on fine needle aspiration biopsy of the thyroid. PTC must be \< 2 cm in maximal diameter on thyroid ultrasound.
• The absence of metastatic cervical lymphadenopathy or gross extrathyroidal extension of 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 with severe compressive symptoms, or primary hyperthyroidism meeting surgical criteria).

You may not qualify if:

• 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 recurrent laryngeal nerve, and with progression would be deemed to be at high risk of growth into these critical structures.
• Clinical signs, imaging, or laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis due to the thyroid cancer or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the 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 may include 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 study follow-up procedures due to current active physical limitations/medical co-morbidity, cognitive, or psychiatric impairment substance abuse, or other reasons.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of British Columbia: collaborator
• University of Calgary: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• McMaster University: collaborator
• CHU de Quebec-Universite Laval: collaborator
• Dalhousie University: collaborator
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (8)

University of Calgary, Cumming School of Medicine

Calgary, Alberta, T2N 2T9, Canada

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Nova Scotia Health

Halifax, Nova Scotia, B3H1V8, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Lawson Health Research Institute

London, Ontario, N6C2R5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Division chirurgie ORL et cervico-faciale

Montreal, Quebec, Canada

Location

CHU de Québec - Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

• Sawka AM, Ghai S, Tomlinson G, Baxter NN, Corsten M, Imran SA, Bissada E, Lebouef R, Audet N, Brassard M, Zhang H, Gupta M, Nichols AC, Morrison D, Johnson-Obeski S, Prisman E, Anderson D, Chandarana SP, Ghaznavi S, Jones J, Gafni A, Matelski JJ, Xu W, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group. A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer. Front Endocrinol (Lausanne). 2021 Jun 10;12:686996. doi: 10.3389/fendo.2021.686996. eCollection 2021.

  PMID: 34194396 BACKGROUND

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Papillary Thyroid Microcarcinoma; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna M Sawka, 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: October 27, 2020
• First Posted: November 10, 2020
• Study Start: February 3, 2021
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)