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An Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T)

A Prospective Multi-centered Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T) in Patients With Thyroid Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06158360
Enrollment
500
Registered
2023-12-06
Start date
2023-12-01
Completion date
2029-12-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer

Brief summary

This observational study aimed to evaluate the safety and efficacy of postoperative management in patients with thyroid cancer who received subtotal or total thyroidectomy.

Detailed description

1. Characteristic analysis of improvement in quality of life and symptoms after surgery in cancer patients 2. Multifaceted symptom evaluation of cancer patients visiting medical institutions 3. Evaluation of effectiveness and safety of treatment for postoperative symptoms in thyroid cancer patients 4. Analysis of the effectiveness and prognosis of cancer-related treatment for each patient with cancer 5. Analysis of prognostic factors for disease-free survival and overall survival of cancer patients Among adult men and women aged 19 years or older who have been diagnosed with thyroid cancer, who have undergone partial or total thyroidectomy and visited the hospital for postoperative management, the characteristics of the visiting patient, quality of life, characteristics of cancer-related symptoms, and treatment effectiveness, We intend to conduct a prospective observational study to evaluate safety and its relationship with prognosis. In addition, we aim to form the basis for follow-up research through the establishment of an Oriental medicine cancer cohort and database.

Interventions

None listed

Sponsors

Ilsan Cha hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 19 years of age or older * Those who have been confirmed to have a malignant tumor of the thyroid gland by biopsy or imaging * Subjects who have undergone partial thyroidectomy or total resection within 1 month * Those who have agreed to the implementation of Chinese medicine treatment * The Eastern Cooperative Oncology Group(ECOG) performance status 0-3 * Those who understand the content of the study and agree to participate in the study

Exclusion criteria

* ○ When it is judged that other diseases other than cancer (dementia, cerebrovascular disease, severe organ failure, etc.) may have a significant effect on the decline of physical function * When it is judged that the life expectancy is less than 3 months and sufficient follow-up cannot be carried out * When emergency or major surgery or surgical intervention is required that takes precedence over postoperative treatment * Pregnant and lactating women * Other researchers who are judged to be unsuitable for research

Design outcomes

Primary

MeasureTime frameDescription
THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposesAt the end of week 1(each cycle is 7days)The THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors using methodologically proven standard guidelines and validated questionnaires to improve symptoms, treatment, follow-up and disease experience in thyThe THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors using methodologically proven standard guidelines and validated questionnaires to improve symptoms, treatment, follow-up and disease experience in thyroid cancer survivors. roid cancer survivors.

Secondary

MeasureTime frameDescription
Change in THYCA-QoL over time seriesAt the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 monthThe THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors using methodologically proven standard guidelines and validated questionnaires to improve symptoms, treatment, follow-up and disease experience in thyThe THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors using methodologically proven standard guidelines and validated questionnaires to improve symptoms, treatment, follow-up and disease experience in thyroid cancer survivors. roid cancer survivors.
EORTC-QLQ-C30At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 monthIt is a health-related questionnaire for cancer patients. It consists of 3 subdomains: overall quality of life, functional area, and symptom domain, a total of 30 items.
BCQAt the end of Day 1, week 1, week 2It is a dialectic tool that divides the physiological and pathological conditions and symptoms of the human body into three dialectics: concession, yinhe, and word-body, and identifies the deteriorated condition of the human body.
CHPIQAt the end of Day 1, week 1, week 2It is a key diagnostic technology that plays a decisive role in the selection of prescriptions in traditional Chinese medicine, and it is a symptom-based cold and heat pattern identification questionnaire that has been recognized for its reliability and validity. CHPIQ).
MDASI-CoreAt the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 monthThe MDASI-core is a 19-item questionnaire that identifies pain, fatigue, nausea, vomiting, insomnia, shortness of breath, cognitive function, anorexia and dysthymia on a 10-point scale.
Oral epithelial cell-based whole genome analysisDay 1The Asia PMRA chip contains more than 300 cancer-related common variants and 2,600 rare variants as well as 2,600 pharmacogenomic-related variants, including more than 300 cancer-related common variants and 2,600 rare variants contained in the ClinVar (\> 43,000 markers) or GWAS Catalog (\> 23,400 markers), which are databases for diseases and various traits.
overall survivalAt the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 monthTo investigate the overall survival of study subjects enrolled in the study and cancer-related deaths, from the time of initiation of cancer-related TCM treatment to death.
Adverse eventsAt the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 monthCTCAE ver. To investigate the types and incidence of adverse events in accordance with 5.0.

Countries

South Korea

Contacts

CONTACTJee Youg Lee
happiade@chamc.co.kr082-31-782-3113
PRINCIPAL_INVESTIGATORJee Youg Lee

Ilsan Cha hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026