Table 3.
Thyroid cancer active surveillance cohorts
| Institution | Estimated enrollment | Inclusion criteria | Exclusion criteria | Outcomes |
|---|---|---|---|---|
| Kuma Hospital, Kuma, Japan131 | n = 1,211 | • Diagnosed using ultrasonography -guided fine- needle aspiration • Absence of distant or nodal metastasis, substantial extrathyroidal extension, aggressive cytology |
• Presence of tumours attached to the trachea or located on the course of the laryngeal nerve | • Timeframe: 10 years • Rate of progression of thyroid papillary microcarcinoma |
| Cancer Instititue Hospital, Tokyo, Japan123 | n = 230 | • Diagnosed using ultrasonography-guided fine- needle aspiration | • Presence of clinically apparent distant metastases, lymphadenopathy (≥1 cm), or extrathyroidal invasion | • Timeframe: 13 years • Rate of progression of thyroid papillary microcarcinoma |
| Seoul National University Hospital, Seoul, South Korea (NCT02938702) | n = 400 | • Diagnosed using fine-needle aspiration or needle biopsy of Bethesda category V or VI • Thyroid cancer <1 cm in diameter |
• Cannot routinely follow up according to the study schedule • Hyperthyroidism that needs treatment |
• Timeframe: 5 years • Rate of progression of thyroid papillary microcarcinoma* • Comparison of rate of disease progression between active surveillance group and surgery group |
| Seoul St. Mary’s Hospital, Seoul, South Korea (NCT02952612) | n = 300 | • <1 cm solitary nodule • Surrounded by ≥2 mm nonmalignant thyroid parenchyma • Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery • No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery • No extrathyroidal extension • N0 and M0 stage disease • Combined severe comorbidities or inoperable condition (optional) • No wish to undergo surgery and willingness to accept active surveillance • No history of radiotherapy to the head and neck area |
• ≥1 cm nodule and/or multifocal nodules, regardless of size • PTC variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant, or other types of thyroid cancer) • Subcapsular locations adjacent to surrounding structures, such as the recurrent laryngeal nerve, trachea, or carotid artery • Evidence of invasion of surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery • Extrathyroidal extension • N1 and/or M1 disease • Documented increase in tumour size, according to ATA guidelines in a previously confirmed papillary thyroid microcarcinoma • Age <18 years |
• Timeframe: 5 years • Progression of papillary thyroid microcarcinoma |
| Memorial Sloan Kettering Cancer Center, New York, NY, USA (NCT02363595) | n = 300 | • Biopsy-proven PTC (or case suspected of being PTC) confirmed by MSKCC cytopathologist • Being followed with active surveillance at MSKCC • Biopsied index nodule ≤2 cm in maximum dimension • Thyroid and neck ultrasonography performed and interpreted by a MSKCC radiologist <6 months prior to study entry |
• Biopsied index nodule >2 cm in any dimension • Age <18 years |
• Time frame: 4 years • Estimate the rate of disease progression |
| Cedars-Sinai Medical Center, Los Angeles, CA, USA (NCT02609685) | n = 216 | • Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma • ≤1.5 cm nodules by ultrasonographic criteria • Ability to understand and the willingness to sign a written informed consent and Health Insurance Portability and Accountability Act authorization form |
• High-grade or poorly differentiated PTC variants • Central or lateral neck lymphadenopathy suspected of being PTC • Unfavorable nodule location (such as near dorsal surface [by recurrent laryngeal nerve]); adjacent to the trachea (risk of cartilage invasion) • History of radiation to neck |
• Time frame: from time of diagnosis up to 10-years of follow up • Rate of disease progression over a 3-year, 5-year, and 10-year period • Percentage of patients electing to undergo surgery despite absence of clinical progression • Impact of thyroid-stimulating hormone suppression on thyroid nodule growth (in cm) as measured using ultrasonography over 5 years • Identify the clinicopathological features associated with disease progression in papillary thyroid microcarcinoma followed with active surveillance by 5 years • Identify the genetic factors associated with an increased risk of disease progression at 5 years • Quality of life score as measured using the City of Hope Quality of Life Scale • Anxiety score as measured using the Memorial Anxiety Scale at 5 years |
ATA, American Thyroid Association; MSKCC, Memorial Sloan Kettering Cancer Center; PTC, papillary thyroid cancer.
*
Progression defined as an increase in tumour size >3 mm in diameter, or a tumour that involves new lymph nodes, or leads to the development of metastases.
‡
Progression defined as any change in the size and/or shape of papillary thyroid microcarcinoma detected using thyroid sonography.