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

Sponsor

Chung Shan Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05557474

Collaborator

National Science and Technology Council (U.S. Fed)

236

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Surgery Recurrence	Other: Early-stage lung cancer prognostic kit -- ELISA Other: Early-stage lung cancer prognostic kit -- IHC

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

236 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Lung cancer post surgery recurrence follow up Lung adenocarcinoma, stage IA/IB/II/IIIA post-surgery follow up	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

Arm

Intervention/Treatment

Lung cancer post surgery recurrence follow up

Lung adenocarcinoma, stage IA/IB/II/IIIA post-surgery follow up

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

Outcome Measures

Primary Outcome Measures

disease free survival [5 years]
Disease free survival

Secondary Outcome Measures

Overall survival [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.