New blood and tissue test could spot High-Risk lung cancer patients early
NCT ID NCT05557474
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing two new diagnostic kits that use blood samples or tumor tissue to predict if early-stage lung cancer will come back after surgery. Researchers will enroll 236 people with stage IA to IIIA lung cancer who have had their tumor fully removed. The goal is to see if these kits can accurately identify patients at higher risk of recurrence, which could help doctors decide on additional treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ELISA and IHC diagnostic kits
- What this could lead to
- If successful, this could help doctors identify which early-stage lung cancer patients are at high risk of recurrence, enabling more tailored follow-up and treatment.
- What could go wrong
- This is a relatively small, single-center study focused on diagnostic accuracy, not a treatment. The kits may not prove reliable enough for widespread use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 236 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Early stage lung adenocarcinoma post-surgical follow up
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chung Shan Medical University Hospital
RECRUITINGTaichung, Taiwan, 402, Taiwan
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National Taiwan University, Cancer Center
RECRUITINGTaipei, 106, Taiwan
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