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Blood, urine, and stool may hold the key to predicting a serious side effect of lung cancer treatment

NCT ID NCT07742800

Knowledge-focused Sponsor: HAN GUANG 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is looking at whether analyzing blood, urine, and stool samples can help predict which lung cancer patients are more likely to develop radiation pneumonitis—a type of lung inflammation—after receiving immunotherapy and radiation therapy. The researchers will collect samples from 160 patients before they start radiation and use advanced analysis to look for patterns that might indicate higher risk. The goal is to create a model that could help doctors personalize treatment and reduce this side effect.

What this could mean

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

Active substance
No therapeutic intervention; observational study collecting blood, urine, and stool samples for multi-omics analysis
What this could lead to
If successful, this could lead to a predictive test that helps doctors identify lung cancer patients at higher risk of radiation pneumonitis before starting radiotherapy, enabling personalized treatment plans.
What could go wrong
The study is observational and relatively small, so the predictive model may not be accurate enough for widespread use. Also, it focuses on a specific patient group, so results may not apply to all lung cancer 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 160 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

This prospective observational cohort study will enroll adult patients with histologically confirmed lung cancer who have received prior immunotherapy and are scheduled to undergo thoracic radiotherapy. Participants will be recruited from the Department of Oncology at Hubei Cancer Hospital. Eligible patients must have no use of antibiotics within 1 week prior to radiotherapy initiation, with no active infection or uncontrolled comorbidities. The study aims to collect blood, urine, and stool samples at baseline for multi-omics profiling. A total of approximately 160 participants will be enrolled.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients aged 18 or older years with a life expectancy of at least 6 months. Additional inclusion criteria were a Zubrod performance status of 0-1, documentation of baseline chest computed tomography (CT) scans prior to the initiation of immunotherapy, receipt of at least 2 cycles of systemic therapy (PD-1) as either monotherapy or combination therapy within the past six months, voluntary participation with written informed consent, and appropriate baseline biochemical tests. The radiation dose for thoracic radiotherapy was ≥30Gy for all eligible patients in this study. No use of antibiotics within 1 week prior to the initiation of thoracic radiotherapy. Exclusion Criteria:Participation in other interventional clinical studies or treatments, having received investigational drugs or treatments within 4 weeks prior to the first dose, or prior receipt of a solid organ or hematopoietic stem cell transplant, having an active infection, or pre-existing/active ICI-induced pneumonitis. \-

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma radiation pneumonitis small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer (NSCLC) Lung cancer (SCLC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430079, China

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