Status:
ACTIVE_NOT_RECRUITING
Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Cancer Society (CCS)
Ontario Ministry of Health and Long Term Care
Conditions:
Thyroid Cancer Stage I
Eligibility:
All Genders
18-100 years
Brief Summary
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 v...
Detailed Description
This is a prospective observational study, consisting of multiple parts. 1. In the first part of the study, eligible, consenting adult patients with low risk papillary thyroid cancer who have not had...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Regional or distant metastatic thyroid cancer
- History of prior thyroid cancer surgery
- High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
- 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
- Medically unfit for surgery due to co-morbidity
- Another active malignancy with limited life expectancy of \< 1 year.
- Pregnancy at the time of study enrollment.
- Other absolute indication for thyroid or parathyroid surgery
- 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.
Key Trial Info
Start Date :
May 11 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03271892
Start Date
May 11 2016
End Date
December 31 2031
Last Update
November 26 2025
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4