NCT03454685

Brief Summary

Relationship between human microbiota and epidemiology of lung cancer

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

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

First Submitted

Initial submission to the registry

January 21, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

January 21, 2018

Last Update Submit

May 31, 2019

Conditions

NSCLC, Stage INSCLC, Stage IINSCLC, Stage IIINSCLC Stage IVHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Relationship Between Human Microbiota and Epidemiology of Lung Cancer

    Find some human microbes that are associated with the development of lung cancer, we can detect these human microbiological content as a biomarker of lung cancer.

    1 year

Study Arms (2)

NCSLC group

NSCLC patients,including stage I to stage IV.

Other: without intervention type

Healthy subjects

healthy subjects

Other: without intervention type

Interventions

without intervention typeOTHER

Without intervention,this study is just an observational study.

Healthy subjectsNCSLC group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Just confirmed non-small cell lung cancer patients

You may qualify if:

  • non-small cell lung cancer patients

You may not qualify if:

  • long-term workers in the polluted environment, Patients who had used antibiotics within 1 month before sampling,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union hospital

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (1)

  • Lu H, Gao NL, Tong F, Wang J, Li H, Zhang R, Ma H, Yang N, Zhang Y, Wang Y, Liang Z, Zeng H, Chen WH, Dong X. Alterations of the Human Lung and Gut Microbiomes in Non-Small Cell Lung Carcinomas and Distant Metastasis. Microbiol Spectr. 2021 Dec 22;9(3):e0080221. doi: 10.1128/Spectrum.00802-21. Epub 2021 Nov 17.

    PMID: 34787462DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We intend to collect the following samples： 1. Blood samples 2. Stool samples 3. Sputum samples 4. Tumor tissue samples

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

  • dong xiaorong, Dr

    china government

    STUDY DIRECTOR

Central Study Contacts

dong xiaorong, Dr

CONTACT

15071116896zrg27@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2018

First Posted

March 6, 2018

Study Start

January 30, 2018

Primary Completion

January 30, 2020

Study Completion

March 30, 2020

Last Updated

June 4, 2019

Record last verified: 2019-05

Locations

CN(1)