NCT03504098

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

March 25, 2018

Last Update Submit

May 27, 2019

Conditions

Keywords

One-carbon metabolismFolateCholinemetabolomic markerCancer risk

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.

Behavioral: nutrition consult

Lung cancer patients

Supply nutrition counseling

Behavioral: nutrition consult

Interventions

Post-lung cancer operation diet pattern

Lung cancer patientsLung cancer patients blood

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample 10c.c lung tumor tissue non-lung tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chin-Pao Cheng

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations