Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early-stage lung cancer prognostic kit -- ELISA, Early-stage lung cancer prognostic kit -- IHC.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Surgery, Recurrence. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit and Immunotherapy Companion Diagnostic Laboratory Developed Tests
Overview
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.
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
Primary outcome measures
- disease free survival [Time frame: 5 years]
Secondary outcome measures (1)
- Overall survival [Time frame: 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 2 centers
- Chung Shan Medical University Hospital — Taichung
- National Taiwan University, Cancer Center — Taipei
Publications
- Yarchoan M, Johnson BA 3rd, Lutz ER, Laheru DA, Jaffee EM. Targeting neoantigens to augment antitumour immunity. Nat Rev Cancer. 2017 Apr;17(4):209-222. doi: 10.1038/nrc.2016.154. Epub 2017 Feb 24. PMID 28233802
- Galon J, Bruni D. Tumor Immunology and Tumor Evolution: Intertwined Histories. Immunity. 2020 Jan 14;52(1):55-81. doi: 10.1016/j.immuni.2019.12.018. PMID 31940273
- Chen YJ, Roumeliotis TI, Chang YH, Chen CT, Han CL, Lin MH, Chen HW, Chang GC, Chang YL, Wu CT, Lin MW, Hsieh MS, Wang YT, Chen YR, Jonassen I, Ghavidel FZ, Lin ZS, Lin KT, Chen CW, Sheu PY, Hung CT, Huang KC, Yang HC, Lin PY, Yen TC, Lin YW, Wang JH, Raghav L, Lin CY, Chen YS, Wu PS, Lai CT, Weng SH, Su KY, Chang WH, Tsai PY, Robles AI, Rodriguez H, Hsiao YJ, Chang WH, Sung TY, Chen JS, Yu SL, Ch PMID 32649875
- Jamal-Hanjani M, Wilson GA, McGranahan N, Birkbak NJ, Watkins TBK, Veeriah S, Shafi S, Johnson DH, Mitter R, Rosenthal R, Salm M, Horswell S, Escudero M, Matthews N, Rowan A, Chambers T, Moore DA, Turajlic S, Xu H, Lee SM, Forster MD, Ahmad T, Hiley CT, Abbosh C, Falzon M, Borg E, Marafioti T, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers PMID 28445112
Identifiers
NCT: NCT05557474 · 110WFD2510303