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Tests kits that flag early-stage lung cancer patients at higher risk of recurrence

Tests blood and tumor markers to identify early lung cancer patients at higher recurrence risk.

Key facts

Who runs it
Chung Shan Medical University
Where
Taichung and Taipei, TaiwanSee the 2 sites
Trial code
Registry title
Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
Status
Recruiting
People taking part
236 people, planned
Started
1 Oct 2021
Expected to end
31 Dec 2028
Type of study
Observational
Treatments tested
  • Early-stage lung cancer prognostic kit -- ELISA
  • Early-stage lung cancer prognostic kit -- IHC
Record updated
17 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage lung adenocarcinoma whose tumour was fully removed by surgery. It tests two kits that identify high-risk disease.

Age
20 years or older
Sex
Men and women can join
Disease stage
Lung adenocarcinoma, pathological stage IA, IB, II or IIIA (AJCC 8th Edition), with complete tumour removal (R0 resection)
Earlier treatment
Complete surgical removal of the tumour (R0 resection)

Main reasons for not taking part

  • Not a primary lung cancer
  • Stage after surgery is not IA, IB, II or IIIA
  • Another cancer that is not under control
  • Uncontrolled systemic disease such as diabetes, hypertension or active infection
  • Pregnant women

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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.)

Who cannot take part

  • 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 )
  • 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
  • Pregnant women

Where in Taiwan

  • Chung Shan Medical University HospitalTaichung, TaiwanContact: GEECHEN CHANG, MD, PhDTaking people
  • National Taiwan University Cancer CenterTaipei, TaiwanContact: Jin-Shing Chen, MD PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Lung cancer post surgery recurrence follow up

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

    Treatment: Early-stage lung cancer prognostic kit -- ELISA and Early-stage lung cancer prognostic kit -- IHC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit and Immunotherapy Companion Diagnostic Laboratory Developed Tests
Plain-language title
Tests kits that flag early-stage lung cancer patients at higher risk of recurrenceGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
17 February 2026