NCT04260295: STARS

Study of the Correlation of Tumor Tissue Microbiome to the Pathogenesis of Lung Cancer

Status unknown Last updated 7 February 2020

What this trial tests

trial in Lung Cancer in 300 participants. Status unknown.

Timeline

1 November 2019

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	Huashan Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 November 2019
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	1 location across China

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Microbiome — all drugs for Microbiome →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 80, any sex, with Lung Cancer or Microbiome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lung cancer is the malignant tumor with the highest incidence, accounting for the first cause of tumor death. At present, smoking, occupational and environmental exposure, air pollution and genetic factors are considered to be related to the incidence of lung cancer. However, the occurrence of cancer is related to many factors. In recent years, researches have found that microorganisms are closely related to various human cancers. It is reported that 20% of cancers are related to multiple microorganisms, such as EB virus and nasopharyngeal cancer, HBV and liver cancer. Understanding the correlation between pathogenic microorganisms and cancer is of great significance for the pathogenesis, prevention and treatment of cancer. Basic researches have found that mycotoxins are related to animal models of lung cancer, but have not been confirmed in clinical and human.

With the help of microbial metagenome Next Generation Sequencing (mNGS) and bioinformatics analysis, the investigators initially found in clinical practice that some patients had fungal infections such as fungi in lung cancer tissues. This study intends to collect clinical cases (cross-sectional studies) to explore the correlation between the pathogenic microbiome and lung cancer, in order to confirm that the occurrence of lung cancer is closely related to microorganisms such as fungi.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Next Generation Sequencing Technology in Lung Cancer Diagnosis.
   Cainap C, Balacescu O, Cainap SS, Pop LA. · · 2021 · cited 62× · PMID 34571741 · DOI 10.3390/biology10090864
2. Tumor microbiome - an integral part of the tumor microenvironment.
   Ciernikova S, Sevcikova A, Stevurkova V, Mego M. · · 2022 · cited 56× · PMID 36505811 · DOI 10.3389/fonc.2022.1063100