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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03504098
Other study ID # 201701123RINC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date July 31, 2020

Study information

Verified date May 2019
Source National Taiwan University Hospital
Contact Jin-Shing Chen
Phone 8862-2312345670918
Email chenjs@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Non-small cell lung cancer (NSCLC) accounts for more than two-thirds of lung cancer, which is the leading cause of cancer deaths in Taiwan. The overall prognosis of NSCLC is poor with low 5-year survival rates. Recent advances suggest that malignancy NSCLC cancers are the cancer stem cell (CSC) diseases. The stemness potentials of CSC with epithelial-mesenchymal transdifferentiation ensure their invasion and disseminate to metastsis organs. The self-renewal property of CSC mediates intrinsic drug resistance to cytotoxicity therapy and promoted aggressive relapse tumour. Metabolic reprogramming on bioenergetics of malignant cancer cells has been proposed as the key mediator in the stemness CSC development. Malignancy cells uptake glucose for fermented glycolysis to produce lactate which release resulted in acidified microenvironment to trigger the mTOR and sonic hedgehog metabolic stress signaling in supporting CSC stemness potentials. The metabostemness of cancer cells is the new-dimensional hallmark of malignancy tumour, which may serve as the diagnostic markers for the early detection of malignancy cancers. Folate-mediated one carbon metabolism coordinates glucose into amino acid metabolism to tailor the fuel metabolites in supporting macromolecule synthesis and to sustain the bioenergetics requirement. Acting as the metabolic stressor, low folate intake is associated with increased risks of lung cancers. Folate and one-carbon nutrient status of NSCLC patients in Taiwan, however, has not been assessed. The role of low folate metabolic stress (LFMS) in metabostemness marker and metastasis potentials of malignancy NSCLC is unexplored. The causal effect and the working mechanisms by which LFMS promoted NSCLC malignancy remain elusive.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- Surgeon diagnosed as the first time having non-small cell lung cancer from the surgical clinic of National Taiwan University Hospital

Exclusion Criteria:

- Patients Suffer from major diseases such as heart, liver, kidney, or peripheral arterial disease, or having mental illness

- Diabetes and non-lung cancer patients

- Pregnancy, breast-feeding pregnant women

Study Design


Intervention

Behavioral:
nutrition consult
Post-lung cancer operation diet pattern

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake of lung cancer patients Using semiquantitative food frequency questionnaires Past 0.5-1 year
Secondary Measure maternal blood biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.) Using blood analysis to calculate the levels of one carbon nutrition At baseline
Secondary Assessment of one-carbon nutrient metabolomic markers in lung cancer patient tumor tissue Using LC/MS or GC/MS to claculate metabolomic markers 3 years
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