Blood test aims to track cancer treatment response in real time

NCT ID NCT05935384

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are studying whether a blood test called Guardant360 can measure how well cancer treatment is working in people with advanced lung, colorectal, or breast cancer. The test looks for tumor DNA that cancer cells release into the bloodstream. Participants give blood samples throughout their treatment, and researchers compare changes in tumor DNA levels with results from standard CT scans. The goal is to see if the blood test can detect disease progression earlier or more conveniently than imaging alone.

What this could mean

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

Active substance
Guardant360, a blood test that looks for tumor DNA in the bloodstream
What this could lead to
If it works, doctors could use a simple blood draw to track whether cancer treatment is working, potentially replacing or reducing the need for repeated scans.
What could go wrong
The blood test may not reliably detect treatment response across all cancer types or treatment regimens. This observational study collects data but does not test whether acting on the blood test results improves patient outcomes.

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 470 people

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

Started

Oct 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The primary study population will include participants with Non-small cell lung cancer (stage III-IV), Colorectal adenocarcinoma (stage III-IV), and Breast Cancer (stage III-IV), as per inclusion/exclusion criteria. Approximately 470 total patients will be enrolled into the study.

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 Each participant must satisfy all the following criteria to be enrolled in the study: 1. Age ≥18 years old 2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study 3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy 4. Able to understand, and capable of providing written consent to participate in the study 5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent 6. Are willing to provide blood samples at enrollment and at subsequent clinical visits 7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as: * Cohort 1: Unresectable Stage III/IV NSCLC (\~125) * Cohort 2: Stage IV Colorectal (\~125) * Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55) * Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55) * Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55) * Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage. Exclusion Criteria Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study: 1. History of prior solid malignancy or hematological malignancy within five years of enrollment 2. Life expectancy ≤12 weeks 3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen 4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression

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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.

  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

  • Orchard Healthcare Research Inc.

    RECRUITING

    Skokie, Illinois, 60077-1384, United States

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