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Blood test may spot lung cancer relapse months early

NCT ID NCT06443684

Knowledge-focused Sponsor: Shanghai Chest Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 305 people with stage III non-small cell lung cancer who have specific genetic mutations. Researchers regularly test their blood for tiny traces of cancer DNA (minimal residual disease, or MRD) to see if it can predict when the cancer will come back. The goal is to find out if MRD testing is more accurate than standard scans for early detection of recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a blood test that warns of lung cancer returning months before scans detect it.
What could go wrong
This is an observational study, not a treatment trial. It may show MRD is not a reliable predictor, or results may not apply to all patients.

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

About 305 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

305 The main research purpose of this project is to associate the MRD status of driver gene positive patients with 12 months of recurrent events. The follow-up is 2 years, so according to the number of patients with stage IIIA NSCLC in each center, and the patient enrollment is planned within 1 year. A total of 305 stage III NSCLC patients were collected

Ages

18 years and older

Sex

Anyone

Show 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: 1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy 2. Age≥ 18 3. ECOG PS:0-1 4. Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\\ALK\\ROS1\\RET\\KRAS\\PIK3CA\\BRAF\\HER2\\MET 5. Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject 6. Provide 20 mL peripheral blood samples periodically 7. The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up Exclusion Criteria: 1. Patients with other malignancies within 5 years 2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival 3. The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000, China

  • Shandong Provincial Hospital

    Jinan, Shandong, China

  • Shanghai Chest hospital

    Shanghai, Shanghai Municipality, China

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of USTC / Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, China

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.