Active Surveillance or Surgery for Primary Management of Very Low Risk Papillary Thyroid Cancer: How Often Are the Long-term Disease Management Goals Achieved?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 8
- 主要终点
- Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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 expectancy of < 1 year).
- •Pregnancy at the time of study enrollment.
- •Unable/unwilling to provide informed consent for the study or comply with study follow-up procedures due to current active physical limitations/medical co-morbidity, cognitive, or psychiatric impairment substance abuse, or other reasons.
结局指标
主要结局
Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management
时间窗: Through study completion, an estimated average of 3 years
'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.
Number of Participants in the Surgical Group who Experience 'Failure' of Surgical Disease Management
时间窗: Through study completion, an estimated average of 3 years
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.
次要结局
- Description of Quality of Life (Thyroid Cancer-specific)(Through study completion, an estimated average of 3 years)
- Number of Participants who Experience Long-term Complications of Thyroid Surgery(Through study completion, an estimated average of 3 years)
- Number of Participants in Respective Thyroid Cancer Disease Status Categories at Last Follow-up(Through study completion, an estimated average of 3 years)
- Number of Participants in the Active Surveillance Group who Undergo Thyroidectomy During Follow-up(Through study completion, an estimated average of 3 years)
- Description of Quality of Life (Cancer-specific)(Through study completion, an estimated average of 3 years)
- Measure of Anxiety(Through study completion, an estimated average of 3 years)
- Measure of Survivor Concerns(Through study completion, an estimated average of 3 years)
- Measure of Decision Regret (relating to the original decision to undergo active surveillance or thyroid surgery).(Through study completion, an estimated average of 3 years)