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

NCT ID: NCT06143436

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2025-05-19

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Constitution in Chinese Medicine Questionnaire

Using questionnaire to collect data from new lung cancer patients.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.) .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Su-Tso Yang, M.D.

Role: CONTACT

002794@tool.caaumed.org.tw

886-4-22052121 ext. 15470

Facility Contacts

Su-Tso Yang, M.D.

Role: primary

002794@tool.caaumed.org.tw

886-4-22052121 ext. 15470

Other Identifiers

CMUH112-REC3-157

Identifier Type: -

Identifier Source: org_study_id