Early Cancer Detection Test - Lung Cancer China

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04216511

Acronym

ECLC

Enrollment

1000

Registered

2020-01-02

Start date

2019-08-22

Completion date

2021-06-30

Last updated

2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Tumor Autoantibody, Early Detection, Indeterminate Pulmonary Nodule

Brief summary

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.

Interventions

DIAGNOSTIC_TESTTumor autoantibody detection

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactChunxue Bai, MD

bai.chunxue@zs-hospital.sh.cn18621170011

Backup ContactJian Zhou, MD

zhou.jian@fudan.edu.cn18221223320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026