Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit

Recruiting

• Conditions: Surgery; Lung Cancer; Recurrence
• Interventions: Other: Early-stage lung cancer prognostic kit -- ELISA; Other: Early-stage lung cancer prognostic kit -- IHC

• Registration Number: NCT05557474
• Lead Sponsor: Chung Shan Medical University

Brief Summary

Lung cancer is the leading cause of cancer mortality worldwide in spite of the advanced progresses in medication and low-dose CT screening. The early-stage lung cancer accounts for less than 50% of newly diagnosed lung cancer in Taiwan, even in stage IB patients proximately 30% still suffer from recurrence and metastasis.

The International Cancer Moonshot Project recently established the first comprehensive proteogenomics profiling of early-stage lung cancer patients in East Asia, revealing a proteomics-informed classification to identify a new "late like" subtype, which can identify a subgroup of early-stage patients with worse clinicopathological features (Cell, Cover story, 2020). This study has been featured in prestigious journals (Nat Rev Clin Oncol; Cancer Discov, 2020) and led to two provisional US patents. In this proposal, taking the discovery from the Cancer Moonshot multiomics database, the investigators aim to translate these findings into clinical utilities. Two subprojects are proposed. (1) Validation of "late-like" protein markers for identifying high-risk early-stage lung cancer: Two IVD kits will be developed, including high-risk early-stage lung cancer IHC prediction kit for tumor staining and high-risk early lung cancer ELISA prediction kit for noninvasive diagnosis. (2) Conducting a prospective clinical trial to evaluate the accuracy of high-risk early-stage lung cancer IHC prediction kit and high-risk early-stage lung cancer ELISA prediction kit.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Willing to sign and provide subject consent.
• Male or female of age 20 or older.
• Patients diagnosed with lung adenocarcinoma by tumor pathology.
• Lung cancer with the pathological stage of IA/IB/II/IIIA according to the American Joint Committee on Cancer Staging Manual (8th Edition).
• Complete tumor resection (R0 resection).
• The East Coast Cancer Clinical Research Collaborative (ECOG) performance status was 0 or 1 at the time of grouping.
• Those willing to provide tumor tissue or cytology specimens (including surgical specimens, tissue biopsy specimens, or cytology specimens), blood and body fluid specimens (for follow-up or disease recurrence, such as urine, malignant pleural effusion, ascites, pericardial fluid, etc.).

Exclusion Criteria

• Not primary lung cancer patients.
• Lung cancer patients whose pathological stage is not IA/IB/II/IIIA according to the American Joint Committee on Cancer Staging Manual (8th Edition) after surgery.
• Patients with uncontrolled malignant tumors other than lung cancer.
• Uncontrolled systemic disease (such as diabetes, hypertension, active infection, etc.) (determined by the principal investigator )
• Pregnant women.
• Any condition may put the patient at serious risk, may affect the interpretation of the trial results, or may seriously interfere with the patient's participation in the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer post surgery recurrence follow up	Early-stage lung cancer prognostic kit -- ELISA	Lung adenocarcinoma, stage IA/IB/II/IIIA post-surgery follow up
Lung cancer post surgery recurrence follow up	Early-stage lung cancer prognostic kit -- IHC	Lung adenocarcinoma, stage IA/IB/II/IIIA post-surgery follow up

Primary Outcome Measures

Name	Time	Method
disease free survival	5 years	Disease free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival	10 years

Trial Locations

Locations (2)

National Taiwan University, Cancer Center; 🇨🇳 Taipei, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan