Active Surveillance for Low-risk Papillary Thyroid Carcinoma

Thyroid Cancer Clinical Trial

— MAeSTro?  

Official title:

Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTroⅡ)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261190
• Other study ID #: H-2308-182-1463
• Status: Not yet recruiting
• Start date: March 4, 2024
• Est. completion date: December 31, 2032

Study information

• Verified date: February 2024
• Source: National Cancer Center, Korea
• Contact: Eun Kyung Lee
• Phone: +82-31-920-1743
• Email: eklee[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 499
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects over 18 years old with a thyroid nodule of = 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology
• subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants.

Exclusion Criteria:

• subjects who are unable or unwilling to attend regular follow-ups..
• subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Carcinoma
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMC-SNU Boramae Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Seoul National University Bundang Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival of the patients with low-risk Papillary Thyroid Cancer who choose Active Surveillance	Disease progression in the following criteria: (1) a size increase of =3 mm in maximum diameter; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical LN metastasis; or (4) clinical or radiological suspicion of a distant metastasis.	At 5years, 10years
Secondary	Disease progression	Defined as follows: primary tumor growth >13 mm in largest diameter or primary tumor 20mm in largest diameter in the active surveillance group, or new metastatic disease or newly diagnosed thyroid cancer in the active surveillance group and surgical group	At 5years, 10years
Secondary	Rate of Participants in the Active Surveillance Group that change to surgery without disease progression	The rate of participants in the active surveillance group who cross over to thyroidectomy without disease progression during follow-up will be reported.	At 5years, 10years
Secondary	Comparison of Quality of Life between the Active Surveillance group and immediate surgery group	The Quality of Life - Thyroid (QOL-Thyroid) questionnaire was 30 items. These are assigned to four scales, each reflecting an aspect of QoL. Physical well-being is measured with two items and 13 questions, psychological well-being with 13 items and 22 questions, social concerns with eight items and 14 questions, and spiritual well-being with seven items and questions. Response options range from '0 = worst outcome' to '10 = best outcome' on an ordinal 11-point scale.	every six months for the first two years, every six month to twelve months thereafter, for up to 10years
Secondary	Measure of Anxiety and Depression	Hospital Anxiety and Depression Scale is a measure developed to measure anxiety and depression symptoms in general hospital visiting patients. it is consists of a total of 14 questions, 7 questions related to anxiety and 7 questions related to depression, and the higher the score, the higher the level of anxiety and depression.	every six months for the first two years, every six month to twelve months thereafter, for up to 10years
Secondary	Measure of Satisfaction with the treatment	minimum score 0, maximum score 40, where a lower number indicates a worse outcome	every six months for the first two years, every six month to twelve months thereafter, for up to 10years
Secondary	Factors influencing patients' decisions regarding disease management	Participants will be asked the reason for choosing Active surveillance or surgery decision is complete for the disease management plan. Each participant will be asked, in a semi-structured interview question, to explain the reason why the disease management strategy that was chosen.	every six months for the first two years, every six month to twelve months thereafter, for up to 10years