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

NCT06143436 | Unknown

• 1 other identifier: CMUH112-REC3-157
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medicine, Chinese Traditional; Body Constitution; Syndrome; Risk Factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• demographic data

  1 day

• disease-related clinical data

  1 day

Interventions

Constitution in Chinese Medicine Questionnaire DIAGNOSTIC_TEST

Using questionnaire to collect data from new lung cancer patients.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with primary lung cancer without any treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.) .

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Syndrome

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Su-Tso Yang, M.D.

CONTACT

886-4-22052121; 002794@tool.caaumed.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: December 20, 2023
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

TW (1)