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

NCT04260295 | Unknown DMC

• 1 other identifier: KY2019-128
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Microbiome

Keywords

Microbiome; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Number of cases of fungi found in lung cancer tissues

  Number of cases of fungi found in lung cancer tissues by pathology and next-generation sequencing of microorganisms

  21 months

• Number of cases of fungi found in non-lung cancer tissues

  Number of cases of fungi found in non-lung cancer tissues by pathology and next-generation sequencing of microorganisms

  21 months

Secondary Outcomes (2)

• Number of cases of microorganisms found in lung cancer tissue

  21 months

• Number of cases of microorganisms found in non-lung cancer tissue

  21 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects of this study are patients with lung shadow confirmed by CT-guided percutaneous lung biopsy. They mainly include infectious diseases of the lung, Tumors and interstitial lung diseases. The subjects are patients who cannot be diagnosed by conventional non-invasive testing methods (including blood, sputum and other specimens) and bronchoscopy, and the patients need to be diagnosed and treated as soon as possible (such as lung tumors, lung infections and other diseases ).

You may qualify if:

• Pulmonary shadow patients, including lung cancer and non-lung cancer patients, whose tissue pathology can be clearly diagnosed by percutaneous lung puncture;
• Age ≥18, ≤80 years, regardless of gender;
• Agree to submit for pathology and pathogen metagenomic sequencing;
• Voluntary signed informed consent.

You may not qualify if:

• Patients with metastatic lung cancer;
• Patients with contraindications to percutaneous lung puncture: those with hemorrhagic disease or severe coagulopathy; those with severe emphysema and cardiopulmonary insufficiency; the lung lesions may be vascular diseases such as hemangioma or arteriovenous fistula Etc .; severe cough cannot be controlled by uncooperatives; active hemoptysis;
• Patients with other tumorous diseases;
• patients with rheumatic diseases;
• Patients with severe primary diseases such as heart, cerebrovascular, liver, kidney, hematopoietic system;
• Patients with moderate to severe renal insufficiency (creatinine clearance ≤50ml/hour);
• Patients with mental illness;
• Pregnancy and lactation;
• Patients who participated in other clinical trials in the past 3 months;
• Staff in the hospital and their families in this research institution.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Obtaining pathological and etiology of lung lesion tissue for examination is a necessary and effective diagnostic measure. Part of the biopsy tissue will be submitted for pathology and immunohistochemical detection, and the other part will be submitted for microbial mNGS detection.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shengqing Li, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, PhD

CONTACT

+8602152887072; shengqingli9655@163.com

Youzhi Zhang, MD

CONTACT

+8602152887072; zhyouzhi1977@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: November 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

CN (1)