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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158360
• Other study ID #: ICICC-OS-23-01
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Ilsan Cha hospital
• Contact: Jee Youg Lee
• Phone: 082-31-782-3113
• Email: happiade[@]chamc.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Bundang Cha Hospital	Gyeonggi-do
Korea, Republic of	Ilsan Cha Hospital	Gyeonggi-do
Korea, Republic of	Gangnam Cha Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ilsan Cha hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes	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.	At the end of week 1(each cycle is 7days)
Secondary	Change in THYCA-QoL over time series	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.	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Secondary	EORTC-QLQ-C30	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.	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Secondary	BCQ	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.	At the end of Day 1, week 1, week 2
Secondary	CHPIQ	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).	At the end of Day 1, week 1, week 2
Secondary	MDASI-Core	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.	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Secondary	Oral epithelial cell-based whole genome analysis	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.	Day 1
Secondary	overall survival	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.	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Secondary	Adverse events	CTCAE ver. To investigate the types and incidence of adverse events in accordance with 5.0.	At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month