Early Cancer Detection Test - Lung Cancer China (ECLC)

December 31, 2019 updated by: Bai Chunxue

Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population

Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
      • Zhengzhou, China
    • Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals diagnosed with lung cancer, benign pulmonary nodule or identified as at-risk healthy volunteer in participating hospitals of this study, from the recruitment starting date, till the end of the study.

Description

Inclusion Criteria:

  • Male or female aged 18 or above.

  • Individuals complying with either of the following

    1. diagnosed as lung cancer (histopathologically confirmed);
    2. diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
    3. without pulmonary nodule but with lung cancer risk factor, age & gender matched recruited lung cancer patients.
  • Participant is willing and able to provide necessary information required in CRF.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • History of any cancer;
  • Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case-Lung Cancer
Patients with definite lung cancer diagnosis
Diagnostic test: Tumor autoantibody detection
Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.
Control
Either patients with benign pulmonary nodule, or healthy individuals without pulmonary nodule but with risk factors to develop lung cancer matched to lung cancer group
Diagnostic test: Tumor autoantibody detection
Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autoantibody panel with best clinical performance in Chinese population
Time Frame: Oct.30, 2020
The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.
Oct.30, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bai Chunxue

Collaborators

Gene Tech (Shanghai) Company Limited

Investigators

  • Principal Investigator: Chunxue Bai, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

December 31, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAALC-007-EarlyCDT Lung China

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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