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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer, Surgery, Recurrence

Intervention / Treatment
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* Other: Early-stage lung cancer prognostic kit -- ELISA
* Other: Early-stage lung cancer prognostic kit -- IHC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer post surgery recurrence follow up<br>Lung adenocarcinoma, stage IA/IB/II/IIIA post-surgery follow up | Other: Early-stage lung cancer prognostic kit -- ELISA<br>* blood sample with ELISA<br>Other: Early-stage lung cancer prognostic kit -- IHC<br>* surgical tumor part with IHC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | Disease free survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Immunohistochemistry, Enzyme-linked Immunosorbent Assay, Laboratory developed tests, Recurrence