Folate One-carbon Malnutrition as the Metabostemness Risk Factor of Malignancy Tumor Development of NSCLC Patients
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 25, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedMay 29, 2019
May 1, 2019
3 years
March 25, 2018
May 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Measure maternal blood biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)
At baseline
Assessment of one-carbon nutrient metabolomic markers in lung cancer patient tumor tissue
3 years
Study Arms (3)
Lung cancer patients tumor
Using to analysis metabolomic markers, one carbon folate nutrition levels in lung cancer patients.
Lung cancer patients blood
Using to analysis folate, B12, homocysteine levels in plasma and RBC. Using to analysis cDNA gene test in buffy coat.
Lung cancer patients
Supply nutrition counseling
Interventions
Post-lung cancer operation diet pattern
Eligibility Criteria
Patients who was diagnosed as the first time having NSCLC from NTUH. Patients have no chronic disease / other cancer / chemotherapy / radiotherapy. Patients at least 20 years old.
You may qualify if:
- Surgeon diagnosed as the first time having non-small cell lung cancer from the surgical clinic of National Taiwan University Hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
blood sample 10c.c lung tumor tissue non-lung tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin-Pao Cheng
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2018
First Posted
April 20, 2018
Study Start
August 1, 2017
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
May 29, 2019
Record last verified: 2019-05