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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03320044
Other study ID # PTHO1702
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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