Clinical trial · Observational
Early Cancer Detection Test - Lung Cancer China
Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor autoantibody detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case-Lung Cancer
- description
- Patients with definite lung cancer diagnosis
- interventionNames
- Diagnostic Test: Tumor autoantibody detection
- label
- Control
- description
- 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
- interventionNames
- Diagnostic Test: Tumor autoantibody detection
Primary outcomes (1)
- measure
- Autoantibody panel with best clinical performance in Chinese population
- timeFrame
- Oct.30, 2020
- description
- The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available