NCT06158360

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2023Dec 2029

First Submitted

Initial submission to the registry

November 6, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6.1 years

First QC Date

November 6, 2023

Last Update Submit

March 25, 2026

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • 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

  • BCQ

    At the end of Day 1, week 1, week 2

  • CHPIQ

    At the end of Day 1, week 1, week 2

  • MDASI-Core

    At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month

  • +3 more secondary outcomes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • â—‹ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bundang Cha Hospital

Gyeonggi-do, South Korea

RECRUITING

Ilsan Cha Hospital

Gyeonggi-do, South Korea

RECRUITING

Gangnam Cha Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Axiom Asia Precision Medicine Research Array (PMRA) chip

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Jee Youg Lee

    Ilsan Cha hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee Youg Lee

CONTACT

082-31-782-3113happiade@chamc.co.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 6, 2023

First Posted

December 6, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

KR(3)