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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03504098
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 29, 2019
Information provided by (Responsible Party):
National Taiwan University Hospital

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
Lung Cancer, Nonsmall Cell Behavioral: nutrition consult

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Study Type : Observational
Estimated 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 : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Group/Cohort 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

Primary Outcome Measures :
  1. Assessment of one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake of lung cancer patients [ Time Frame: 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.) [ Time Frame: 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 [ Time Frame: 3 years ]
    Using LC/MS or GC/MS to claculate metabolomic markers

Biospecimen Retention:   Samples Without DNA

blood sample 10c.c

lung tumor tissue

non-lung tumor tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03504098

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Contact: Jin-Shing Chen 8862-2312345670918
Contact: Rwei-Fen S.Huang 8862-29052512

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen    8862-23123456-70918   
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Chin-Pao Cheng National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT03504098    
Other Study ID Numbers: 201701123RINC
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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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:
One-carbon metabolism
metabolomic marker
Cancer risk
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Nutrition Disorders
Carcinoma, Bronchogenic
Bronchial Neoplasms