Clinical trial NCT06158360: An Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T)
Official title: A Prospective Multi-centered Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T) in Patients with Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Lead sponsor: Ilsan Cha hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes
timeFrame: At the end of week 1(each cycle is 7days)
Secondary outcomes:
measure: Change in THYCA-QoL over time series
timeFrame: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
measure: EORTC-QLQ-C30
timeFrame: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
measure: BCQ
timeFrame: At the end of Day 1, week 1, week 2
measure: CHPIQ
timeFrame: At the end of Day 1, week 1, week 2
measure: MDASI-Core
timeFrame: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
measure: Oral epithelial cell-based whole genome analysis
timeFrame: Day 1
measure: overall survival
timeFrame: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
measure: Adverse events
timeFrame: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Bundang Cha Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ilsan Cha Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Cha Hospital
Study officials:
affiliation: Ilsan Cha hospital
name: Jee Youg Lee
role: PRINCIPAL_INVESTIGATOR
References: