Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

Carcinoma Clinical Trial

Official title:

Genetic Variations,Immuno-sequencing and Circulating Tumor DNA(ctDNA) for Early Diagnosis of Small Pulmonary Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320044
• Other study ID #: PTHO1702
• Status: Completed
• Start date: October 18, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Description:

Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sign informed consent and consent to participate in this study;

2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria:

1. Malignant tumor history within the past 5 years;

2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;

3. Histology confirmed not non-small cell lung cancer

4. No matching tissue or blood samplesUnqualified blood samples

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasm
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer		6 months
Secondary	The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer		6 months
Secondary	The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer		6 months