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

NCT05557474 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Science and Technology Council

    collaborator FED

  • Chung Shan Medical University

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557474 on ClinicalTrials.gov