Clinical trial NCT04624477: Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer
Official title: Active Surveillance or Surgery for Primary Management of Very Low Risk Papillary Thyroid Cancer: How Often Are the Long-term Disease Management Goals Achieved?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: University of Calgary
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: McMaster University
name: CHU de Quebec-Universite Laval
name: Dalhousie University
name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
name: Centre hospitalier de l'UniversitÃ© de MontrÃ©al (CHUM)
First posted: 2020-11-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management
timeFrame: Through study completion, an estimated average of 3 years
measure: Number of Participants in the Surgical Group who Experience 'Failure' of Surgical Disease Management
timeFrame: Through study completion, an estimated average of 3 years
Secondary outcomes:
measure: Number of Participants in Respective Thyroid Cancer Disease Status Categories at Last Follow-up
timeFrame: Through study completion, an estimated average of 3 years
measure: Number of Participants in the Active Surveillance Group who Undergo Thyroidectomy During Follow-up
timeFrame: Through study completion, an estimated average of 3 years
measure: Number of Participants who Experience Long-term Complications of Thyroid Surgery
timeFrame: Through study completion, an estimated average of 3 years
measure: Description of Quality of Life (Thyroid Cancer-specific)
timeFrame: Through study completion, an estimated average of 3 years
measure: Description of Quality of Life (Cancer-specific)
timeFrame: Through study completion, an estimated average of 3 years
measure: Measure of Anxiety
timeFrame: Through study completion, an estimated average of 3 years
measure: Measure of Survivor Concerns
timeFrame: Through study completion, an estimated average of 3 years
measure: Measure of Decision Regret (relating to the original decision to undergo active surveillance or thyroid surgery).
timeFrame: Through study completion, an estimated average of 3 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Cumming School of Medicine
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Division chirurgie ORL et cervico-faciale
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
Study officials:
affiliation: University Health Network, Toronto
name: Anna M Sawka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.