Clinical trial Recruiting at 2 sites Observational Ages 20 and up

Prognostic kit for early-stage lung cancer

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

Run by Chung Shan Medical University · NCT05557474 · Data updated 2026-11-12

This study is testing a new kit to help predict the chances of lung cancer coming back in patients who have had early-stage lung adenocarcinoma surgery.

Quick facts

Study typeObservational
Ages20 Years and up
SexAll
Enrollment236 (estimated)
SponsorChung Shan Medical University
Academic / other
Locations2 sites (Taichung, Taiwan and 1 other locations)
StatusRecruiting
StartedOctober 1, 2021
Main results expectedDecember 31, 2026
Study endsDecember 31, 2028
Registry record updatedFebruary 17, 2026
Trial IDNCT05557474 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 20 or older diagnosed with lung adenocarcinoma at stages IA, IB, II, or IIIA who have undergone complete tumor resection.

Probably not a fit

Patients with primary lung cancer at stages other than IA, IB, II, or IIIA, or those who have not undergone complete tumor resection may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and clinically validate a prognostic kit for early-stage lung cancer by utilizing proteogenomics profiling. It focuses on patients diagnosed with lung adenocarcinoma who have undergone complete tumor resection. The research leverages findings from the International Cancer Moonshot Project to identify subtypes of lung cancer that may have worse outcomes. The study will involve collecting tumor and blood specimens to assess the effectiveness of the prognostic kit in predicting recurrence and metastasis.

Why it matters

Potential benefit: If successful, this prognostic kit could significantly improve the ability to predict recurrence in early-stage lung cancer patients, leading to better management and treatment strategies.

How similar studies have gone: Other studies utilizing proteogenomics and similar prognostic approaches have shown promise, indicating potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Chung Shan Medical University Hospital
    Taichung, Taiwan, Taiwan
    Recruiting
  • National Taiwan University, Cancer Center
    Taipei, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.