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NCT Number: NCT06158360

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

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

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bundang Cha Hospital, Gyeonggi-do, South Korea

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About this study

  • Characteristic analysis of improvement in quality of life and symptoms after surgery in cancer patients
  • Multifaceted symptom evaluation of cancer patients visiting medical institutions
  • Evaluation of effectiveness and safety of treatment for postoperative symptoms in thyroid cancer patients
  • Analysis of the effectiveness and prognosis of cancer-related treatment for each patient with cancer
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jee Youg Lee

CONTACT

[email protected]

082-31-782-3113

Sponsors and collaborators

Lead sponsor

Ilsan Cha hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Dec 6, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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