NCT03271892Active, not recruiting
Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer
Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
This is a prospective observational study. 1. In the first part of the study, consenting eligible adult patients with low risk papillary thyroid cancer that is confined to the thyroid, are provided verbal and written information about their disease and the option of active surveillance (close monitoring with intention to treat if disease progresses or if the patient changes her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional standard of care). Patients are free to make their own disease management choice (ie. active surveillance or thyroidectomy) and the investigators are examining how often patients choose each of these options. The investigators are also examining the reasons for their choice. 2. In the second part of the study, consenting, eligible patients who completed the preceding part of the study and chose either a) active surveillance, or b) thyroid surgery, are tracked with respect to clinical and psychosocial outcomes as well as quality of life. Patients who chose active surveillance are free to change their mind and have surgery at any point, even if the disease does not progress. The primary study outcome is decision regret at one year, in the respective groups of patients who chose active surveillance or thyroidectomy.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 28 Aug 2017
- Start date
- 11 May 2016
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Thyroid cancer
- NCT number
- NCT03271892
What you commit to
- Study type: Observational
- Planned participants: 200
- From 11 May 2016 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior thyroid cancer surgery
- Medically unfit for surgery due to co-morbidity
- Other absolute indication for thyroid or parathyroid surgery
Other illness
- Regional or distant metastatic thyroid cancer
- The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus)
- Known or suspected poorly differentiated or non-papillary thyroid cancer
- Another active malignancy with limited life expectancy of \< 1 year.
- Unable to provide informed consent for the study or comply with study follow-up procedures due to current severe active cognitive or psychiatric impairment, substance abuse, or other reasons.
Other
- High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
- Pregnancy at the time of study enrollment.
Who the study is looking for
- Patients 18 years of age or older
- Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC).
- PTC must be less than 2 cm in maximal diameter on thyroid ultrasound
- No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer.
- No other absolute indications for thyroid or parathyroid surgery
- Permission for review of thyroid cancer-related medical records
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.