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

Recruiting

• Conditions: Thyroid Cancer

• Registration Number: NCT06158360
• Lead Sponsor: Ilsan Cha hospital

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.

Study Timeline

• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-28
• Study Start: 2023-12-01
• Study First Posted: 2023-12-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes	At 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 Outcome Measures

Name	Time	Method
CHPIQ	At the end of Day 1, week 1, week 2	It 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).
Oral epithelial cell-based whole genome analysis	Day 1	The 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.
EORTC-QLQ-C30	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month	It 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.
MDASI-Core	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month	The 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.
overall survival	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month	To 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 events	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month	CTCAE ver. To investigate the types and incidence of adverse events in accordance with 5.0.
Change in THYCA-QoL over time series	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month	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.
BCQ	At the end of Day 1, week 1, week 2	It 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.

Trial Locations

Locations (3)

Bundang Cha Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Ilsan Cha Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Gangnam Cha Hospital; 🇰🇷 Seoul, Korea, Republic of