Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

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.

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.

Ogemdi Ihekire

Anna Sawka

Martin Corsten

Martin Corsten, MD

Halema Khan

Anthony Nichols, MD

Deric Morrison, MD

Stephanie Johnson-Obaseki

Stephanie Johnson-Obaseki, MD

Anna M Sawka, MD

David P Goldstein, MD, MSc

Anna M Sawka, MD, PhD

Sarah Chouinard-Castonguay

Maryse Brassard, MD

Nathalie Audet, MD

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.

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.

Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer

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

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

'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.

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.

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.

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.

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.

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.

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.

Generalized Anxiety Disorder Screener questionnaire (minimum score 0, maximum score 21, where a higher score indicates a worse outcome)

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)

Decision Regret Scale (minimum score 0, maximum score 100, where a higher number indicates a worse outcome)

University of British Columbia

University of Calgary

Lawson Health Research Institute

Ottawa Hospital Research Institute

McMaster University

CHU de Quebec-Universite Laval

Centre hospitalier de l'Université de Montréal (CHUM)

Dalhousie University

Canadian Institutes of Health Research (CIHR)

Canadian Cancer Society (CCS)

University Health Network, Toronto

Carcinoma, Papillary

Neoplasms, Squamous Cell

Surgery

Luciano Pezzullo

Clorinda Schettino

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

A further objective is to identify events associated with high risk of local recurrence and distant metastases.

Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) within 1 year from the diagnosis

EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis

Evaluate the number of patients developing anxiety/depression (Hospital Anxiety and Depression Scale) (HADS scale, Each item on the questionnaire is scored from 0-3 and) in the two groups

Evaluate the number of patients developing adverse events (CTCAE 5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer	NCT04624477	Papillary Thyro... Papillary Thyro... Papillary Micro...		18 Years -	University Health Network, Toronto
Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma	NCT04129281	Papillary Micro...	Surgery	18 Years -	National Cancer Institute, Naples
Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma	NCT04129281	Papillary Micro...	Surgery	18 Years -	National Cancer Institute, Naples

Spots Global Cancer Trial Database for papillary microcarcinoma of the thyroid