NCT05557474 Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
| NCT ID | NCT05557474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chung Shan Medical University |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 236 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 236 participants in total. It began in 2021-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05557474 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05557474 currently recruiting?
Yes, NCT05557474 is actively recruiting participants. Contact the research team at geechen@gmail.com for enrollment information.
Where is the NCT05557474 trial being conducted?
This trial is being conducted at Taichung, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT05557474 clinical trial?
NCT05557474 is sponsored by Chung Shan Medical University. The trial plans to enroll 236 participants.
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