Early Cancer Detection Test - Lung Cancer China

NCT04216511 | Unknown

• 1 other identifier: CAALC-007-EarlyCDT Lung China
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Tumor Autoantibody; Early Detection; Indeterminate Pulmonary Nodule

Outcome Measures

Primary Outcomes (1)

• Autoantibody panel with best clinical performance in Chinese population

  The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.

  Oct.30, 2020

Study Arms (2)

Case-Lung Cancer

Patients with definite lung cancer diagnosis

Diagnostic Test: Tumor autoantibody detection

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

Interventions

Tumor autoantibody detection DIAGNOSTIC_TEST

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

Case-Lung Cancer; Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female aged 18 or above.
• Individuals complying with either of the following
• diagnosed as lung cancer (histopathologically confirmed);
• diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bai Chunxue: lead
• Gene Tech (Shanghai) Company Limited: collaborator

Study Sites (3)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Henan Province People's Hospital

Zhengzhou, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum or plasma

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chunxue Bai, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunxue Bai, MD

CONTACT

18621170011; bai.chunxue@zs-hospital.sh.cn

Jian Zhou, MD

CONTACT

18221223320; zhou.jian@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 2, 2020
• Study Start: August 22, 2019
• Primary Completion: October 1, 2020
• Study Completion: June 1, 2021
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

CN (3)