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Trial Title:
TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.
NCT ID:
NCT06143436
Condition:
Medicine, Chinese Traditional
Body Constitution
Syndrome
Risk Factors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Constitution in Chinese Medicine Questionnaire
Description:
Using questionnaire to collect data from new lung cancer patients.
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.
Criteria for eligibility:
Study pop:
Patients who have been diagnosed with primary lung cancer without any treatment.
Sampling method:
Non-Probability Sample
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.) .
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung City
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Su-Tso Yang, M.D.
Phone:
886-4-22052121
Phone ext:
15470
Email:
002794@tool.caaumed.org.tw
Start date:
December 20, 2023
Completion date:
May 19, 2025
Lead sponsor:
Agency:
China Medical University Hospital
Agency class:
Other
Source:
China Medical University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06143436