Early Cancer Detection Test - Lung Cancer China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-22

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case-Lung Cancer

Patients with definite lung cancer diagnosis

Tumor autoantibody detection

Intervention Type DIAGNOSTIC_TEST

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

Tumor autoantibody detection

Intervention Type DIAGNOSTIC_TEST

Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.

Interventions

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Tumor autoantibody detection

Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes