TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.

A Study on the Correlation Between TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.

Recently, TCM has played an important role in adjuvant therapy for lung cancer. TCM treatment is based on pattern identification, and constitution theory is also used as a tool for TCM to predict the disease progression. Although there have been many researchs related to the pattern identification and constitution of lung cancer, in view of the problems and limitations, further research on lung cancer patients in Taiwan is needed.

This study aims to explore the correlation between TCM constitution, pattern identification, and other related factors in patients with primary lung cancer in Taiwan, hoping to reveal the disease characteristics of lung cancer in TCM theory. This study intends to interview subjects through attending physicians in the thoracic ward and outpatient clinic of the CMUH from November 20th, 2023 to May 19th , 2025, and the subjects will be included in this study after the researchers ask the subjects for consent.

This study will collect the demographic data of the subjects (sex, age, BMI, smoking history) and disease-related clinical data (tumor stage, pathological type, gene mutation, tumor markers, other comorbidities), and the investigator will ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ) , ask the subjects' symptoms according to the pattern identification table, obtain the data to analyze their distribution by descriptive statistics, and then analyze the correlation between them by analysis of variance and Chi-square test.

Study Overview

• Status: Recruiting
• Conditions: Syndrome; Risk Factors; Body Constitution; Medicine, Chinese Traditional
• Intervention / Treatment: Diagnostic test: Constitution in Chinese Medicine Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Su-Tso Yang, M.D.; Phone Number: 15470 886-4-22052121; Email: 002794@tool.caaumed.org.tw

Study Locations

• Taiwan
  • Taichung City, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Su-Tso Yang, M.D.; Phone Number: 15470 886-4-22052121; Email: 002794@tool.caaumed.org.tw

Participation Criteria

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 primary lung cancer without any treatment.

Description

Inclusion Criteria:

• Patients diagnosed with primary lung cancer.
• Age greater than 18 years and less than 100 years.
• After explanation, they agree to join this study and voluntarily sign the subject consent form, and can understand the content of the questionnaire.

Exclusion Criteria:

• Pregnant women.
• Severe mental illness that affects the response to the questionnaire.
• Has been treated (e.g., surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, etc.).
• Concomitant with other uncured primary malignancies.
• Patients with other serious primary diseases (such as: liver and kidney dysfunction, hematolymphatic system diseases, etc.).
• Severe respiratory diseases that are not lung cancer (e.g. primary emphysema, interstitial fibrosis, etc.) .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCM body constitution	Ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ)	20-30 minuts
TCM pattern types	Ask about the subjects' symptoms according to the pattern identification table	20-30 minuts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic data	sex, age, BMI, smoking history	1 day
disease-related clinical data	tumor stage, pathological type, gene mutation, tumor markers, other comorbidities	1 day

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): May 19, 2025
• Study Completion (Estimated): May 19, 2025

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CMUH112-REC3-157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No