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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
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• 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.).

Locations
Other Locations
Taiwan
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Taiwan University, Cancer Center
RECRUITING
Taipei
Contact Information
Primary
GeeChen Chang, MD. PhD
geechen@gmail.com
+886-4-24739595
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 236
Treatments
Lung cancer post surgery recurrence follow up
Lung adenocarcinoma, stage IA/IB/II/IIIA post-surgery follow up
Related Therapeutic Areas
Sponsors
Collaborators: National Science and Technology Council
Leads: Chung Shan Medical University

This content was sourced from clinicaltrials.gov