Blood test aims to track cancer treatment response in real time
NCT ID NCT05935384
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
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About 470 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 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 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.
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The places running it
1 site. 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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Orchard Healthcare Research Inc.
RECRUITINGSkokie, Illinois, 60077-1384, United States
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