Prognostic kit for early-stage lung cancer

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

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 type: Observational
• Enrollment: 236 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Chung Shan Medical University (other)
• Locations: 2 sites (Taichung, Taiwan and 1 other locations)
• Trial ID: NCT05557474 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

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.

Where this trial is running

Taichung, Taiwan and 1 other locations

• Chung Shan Medical University Hospital — Taichung, Taiwan, Taiwan (RECRUITING)
• National Taiwan University, Cancer Center — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: GeeChen Chang, MD. PhD

Conditions: Lung Cancer, Surgery, Recurrence, Immunohistochemistry, Enzyme-linked Immunosorbent Assay, Laboratory developed tests