Medicine, Chinese TraditionalNCT06143436
TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.
An observational study of Medicine, Chinese Traditional and Body Constitution, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Medicine, Chinese Traditional, Body Constitution, Syndrome
- What is being tested?
- Constitution in Chinese Medicine Questionnaire
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Dec 2023to 19 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with primary lung cancer without any treatment.
Who may be able to join
- 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.
Who cannot join
- 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.) .
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Su-Tso Yang, M.D., 886-4-22052121 ext. 15470, 002794@tool.caaumed.org.tw
About this study
Official title: 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.
- Being tested
- Constitution in Chinese Medicine Questionnaire
- Medical subject headings
- Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constitution in Chinese Medicine QuestionnaireDiagnostic test
Using questionnaire to collect data from new lung cancer patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
TCM body constitution
Ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ)
Measured: 20-30 minuts
TCM pattern types
Ask about the subjects' symptoms according to the pattern identification table
Measured: 20-30 minuts
Secondary outcomes (2)
demographic data
sex, age, BMI, smoking history
Measured: 1 day
disease-related clinical data
tumor stage, pathological type, gene mutation, tumor markers, other comorbidities
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start20 Dec 2023
- Primary completion19 May 2025 (estimated)
- Study completion19 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medicine, Chinese TraditionalStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143436
- Sponsor's protocol ID
- CMUH112-REC3-157
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation Between TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.
- ClinicalTrials.gov ID
- NCT06143436
- Acronym / sponsor ID
- CMUH112-REC3-157
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 19 May 2025 (estimated)
- Study completion
- 19 May 2025 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with primary lung cancer without any treatment.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constitution in Chinese Medicine QuestionnaireUsing questionnaire to collect data from new lung cancer patients. | Diagnostic test | – |
Primary outcome
TCM body constitution
Time frame: 20-30 minuts
Ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ)
TCM pattern types
Time frame: 20-30 minuts
Ask about the subjects' symptoms according to the pattern identification table
2 secondary outcomes
demographic data
Time frame: 1 day
disease-related clinical data
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medicine, Chinese Traditional and Body Constitution, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su-Tso Yang, M.D. (886-4-22052121 ext. 15470, 002794@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM body constitution (time frame: 20-30 minuts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.