Folate One-carbon Malnutrition as the Metabostemness Risk Factor of Malignancy Tumor Development of NSCLC Patients

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03504098
Collaborator
(none)
300
1
36
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: nutrition consult

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Folate One-carbon Malnutrition as the Metabostemness Risk Factor of Malignancy Tumor Development and the Prognostic Predictor of Non-small Cell Lung Cancer Patients
Actual Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Jul 31, 2020
Anticipated Study Completion Date :
Jul 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: nutrition consult
Post-lung cancer operation diet pattern

Lung cancer patients

Supply nutrition counseling

Behavioral: nutrition consult
Post-lung cancer operation diet pattern

Outcome Measures

Primary Outcome Measures

  1. Assessment of one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake of lung cancer patients [Past 0.5-1 year]

    Using semiquantitative food frequency questionnaires

Secondary Outcome Measures

  1. Measure maternal blood biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.) [At baseline]

    Using blood analysis to calculate the levels of one carbon nutrition

  2. Assessment of one-carbon nutrient metabolomic markers in lung cancer patient tumor tissue [3 years]

    Using LC/MS or GC/MS to claculate metabolomic markers

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Chin-Pao Cheng, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03504098
Other Study ID Numbers:
  • 201701123RINC
First Posted:
Apr 20, 2018
Last Update Posted:
May 29, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 29, 2019