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

November 28, 2023 updated by: Jee Young Lee, Ilsan Cha hospital

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Bundang Cha Hospital
        • Contact:
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Ilsan Cha hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Cha Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed with thyroid cancer (KCD C73) according to the ICD-10 International Classification of Diseases and have been recommended for postoperative management treatment by a physician or acupuncturist

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes
Time Frame: 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.
At the end of week 1(each cycle is 7days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in THYCA-QoL over time series
Time Frame: 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.
At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
EORTC-QLQ-C30
Time Frame: 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.
At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
BCQ
Time Frame: 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.
At the end of Day 1, week 1, week 2
CHPIQ
Time Frame: 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).
At the end of Day 1, week 1, week 2
MDASI-Core
Time Frame: 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.
At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Oral epithelial cell-based whole genome analysis
Time Frame: 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.
Day 1
overall survival
Time Frame: 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.
At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Adverse events
Time Frame: 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.
At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilsan Cha hospital

Investigators

  • Principal Investigator: Jee Youg Lee, Ilsan Cha hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICICC-OS-23-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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