Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer (NCT04624477) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer
Canada450 participantsStarted 2021-02-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ex…
What they're measuring
1
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
2
Number of Participants in the Surgical Group who Experience 'Failure' of Surgical Disease Management
Timeframe: Through study completion, an estimated average of 3 years