Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer

February 3, 2021 updated by: University Health Network, Toronto

Active Surveillance or Surgery for Primary Management of Very Low Risk Papillary Thyroid Cancer: How Often Are the Long-term Disease Management Goals Achieved?

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V8
        • Recruiting
        • Nova Scotia Health
        • Contact:
          • Martin Corsten
          • Phone Number: (902) 473-4420
        • Principal Investigator:
          • Martin Corsten, MD
    • Ontario
      • London, Ontario, Canada, N6C2R5
        • Recruiting
        • Lawson Health Research Institute
        • Contact:
        • Principal Investigator:
          • Anthony Nichols, MD
        • Principal Investigator:
          • Deric Morrison, MD
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
          • Stephanie Johnson-Obaseki
        • Contact:
          • Phone Number: 78596 (613) 798-5555
        • Principal Investigator:
          • Stephanie Johnson-Obaseki, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
        • Contact:
        • Contact:
        • Principal Investigator:
          • David P Goldstein, MD, MSc
    • Quebec
      • Québec, Quebec, Canada, G1V 4G2
        • Recruiting
        • CHU de Québec - Université Laval
        • Contact:
        • Principal Investigator:
          • Maryse Brassard, MD
        • Principal Investigator:
          • Nathalie Audet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

  • 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).

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management
Time Frame: Through study completion, an estimated average of 3 years
'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
Time Frame: Through study completion, an estimated average of 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Respective Thyroid Cancer Disease Status Categories at Last Follow-up
Time Frame: Through study completion, an estimated average of 3 years
The category of thyroid cancer disease status at last follow-up is recorded at least yearly. For patients in the active surveillance arm, disease status categories include: a) alive with no disease progression, b) alive with cross-over to surgery (with indication for surgery, including disease progression or other reason), c) death due to thyroid cancer, or d) death from any cause. For surgical patients and patients who crossed over to surgery from active surveillance, post-surgical disease status categories include: a) alive with no evidence of thyroid cancer structural disease at last follow-up (e.g.. no evidence of thyroid cancer on imaging or biopsy), b) alive with evidence of thyroid cancer structural disease present at last follow-up (i.e. evidence of thyroid cancer on imaging or biopsy), c) death due to thyroid cancer, or d) death from any cause.
Through study completion, an estimated average of 3 years
Number of Participants in the Active Surveillance Group who Undergo Thyroidectomy During Follow-up
Time Frame: Through study completion, an estimated average of 3 years
The number of participants in the active surveillance group who cross over to thyroidectomy during follow-up (with the specific indication for the thyroidectomy and type of thyroid surgery) will be reported.
Through study completion, an estimated average of 3 years
Number of Participants who Experience Long-term Complications of Thyroid Surgery
Time Frame: Through study completion, an estimated average of 3 years
For patients who undergo thyroidectomy during the study, the presence of long-term surgical complications (> 1 year after initial completion of surgery) will be reported. Specific surgical complications that will be tracked include: a) hypoparathyroidism (requiring prescription treatment), or b) recurrent laryngeal nerve injury.
Through study completion, an estimated average of 3 years
Description of Quality of Life (Thyroid Cancer-specific)
Time Frame: Through study completion, an estimated average of 3 years
EORTC QLQ-THY34 (all respective scales). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. All of the scales and single item measures range in score from 0 to 100. A high score for the symptom scales and single items indicates a worse outcome, whereas a high score for the Social Support scale represents a high level of functioning.
Through study completion, an estimated average of 3 years
Description of Quality of Life (Cancer-specific)
Time Frame: Through study completion, an estimated average of 3 years
EORTC QLQ-C30 (all respective scales). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning (better outcome), a high score for the global health status /quality of life represents a better outcome, but a high score for a symptom scale / item represents a worse outcome.
Through study completion, an estimated average of 3 years
Measure of Anxiety
Time Frame: Through study completion, an estimated average of 3 years
Generalized Anxiety Disorder Screener questionnaire (minimum score 0, maximum score 21, where a higher score indicates a worse outcome)
Through study completion, an estimated average of 3 years
Measure of Survivor Concerns
Time Frame: Through study completion, an estimated average of 3 years
Assessment of Survivor Concerns questionnaire (Cancer Worry Subscale - minimum score 3, maximum score 12, where a higher score indicates a worse outcome and General Health Worry Subscale - minimum score 2, maximum score 8, where a higher score indicates a worse outcome)
Through study completion, an estimated average of 3 years
Measure of Decision Regret (relating to the original decision to undergo active surveillance or thyroid surgery).
Time Frame: Through study completion, an estimated average of 3 years
Decision Regret Scale (minimum score 0, maximum score 100, where a higher number indicates a worse outcome)
Through study completion, an estimated average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

University of British Columbia
Canadian Institutes of Health Research (CIHR)
CHU de Quebec-Universite Laval
Centre hospitalier de l'Université de Montréal (CHUM)
McMaster University
Ottawa Hospital Research Institute
University of Calgary
Lawson Health Research Institute
Dalhousie University
Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Anna M Sawka, MD, PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2021

Primary Completion (ANTICIPATED)

March 31, 2025

Study Completion (ANTICIPATED)

March 31, 2030

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-5102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual sites will have access to individual participant data from their own site.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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