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Simple blood and tissue tests could revolutionize lung cancer care

NCT ID NCT05665504

Diagnosis Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether certain biomarkers in blood and lung tissue can help doctors tell if a lung nodule is cancer, predict the risk of cancer coming back after surgery, and monitor for late recurrence. Researchers will follow 250 people with suspicious lung nodules or recent lung cancer surgery. The goal is to improve diagnosis and personalize follow-up care.

What this could mean

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

Active substance
DetermaRX (tissue biomarker test), LCDT-1, NodifyXL2, CIZ1b (blood biomarker tests)
What this could lead to
If successful, these biomarker tests could help doctors more accurately diagnose lung nodules, decide who needs chemotherapy after surgery, and catch cancer returning earlier.
What could go wrong
This is an observational study, not a treatment trial. The tests may not prove accurate enough to change standard care, and 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 250 people

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

Started

Jan 2023

Expected to finish

Feb 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

Patients seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.

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: * Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \[clinical stage IA-IB (cT1a-T2aN0), \<4cm diameter\]. * If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center. * If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center. * \>18 years old, male or female. * ECOG performance status 0-1. * Agree to participate in the follow-up protocol. * Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma). * Ability to understand and the willingness to sign a written, informed consent document. Exclusion Criteria: * Participants who are actively receiving any cancer treatment. * Participants with uncontrolled intercurrent illness. * Prior lung cancer within 5 years. * Current active other major cancer except non-melanoma skin cancer. * Patients with pure ground glass opacities (nodules) or hilar masses. * Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma). * Metastatic nodule (suspected) in the lung from an extrapulmonary cancer. * Patient unable to provide informed consent. * Prisoner or incarcerated individual. * For surgical patients, a R1 or R2 resection.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung lung adenocarcinoma lung cancer

As listed by the trial registrant

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

Adenocarcinoma of lung Lung; node

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

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

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