NCT05557474

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

Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit and Immunotherapy Companion Diagnostic Laboratory Developed Tests

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 236 (estimated)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Surgery
• Recurrence

Interventions

Type	Name	Description
OTHER	Early-stage lung cancer prognostic kit -- ELISA	blood sample with ELISA
OTHER	Early-stage lung cancer prognostic kit -- IHC	surgical tumor part with IHC

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2022-09-28
• Last updated: 2026-02-17

Locations

2 sites across 1 country: Taiwan