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Blood test may help overcome barriers to colon cancer screening

NCT ID NCT06444542

Knowledge-focused Sponsor: Milton S. Hershey Medical Center 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study with 297 participants examined if offering a blood-based screening test (Guardant Shield) encourages people who previously avoided stool tests or colonoscopy to get screened for colorectal cancer. Participants were adults aged 45-75 at average risk who had not completed a recommended screening. The study measured their preference for the blood test and tracked how many chose it over time.

What this could mean

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

Active substance
Guardant Shield blood-based colorectal cancer screening test
What this could lead to
If successful, this could show that a simple blood test boosts screening rates in people who avoid traditional methods, potentially catching more cancers early.
What could go wrong
This is a completed behavioral study, not a treatment trial. It measures preferences and adoption rates, not health outcomes, so it won't directly prove the test saves lives.

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

297 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2025

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 who failed to complete a stool-based screening test or a colonoscopy six months after receiving an order from their providers

Ages

45 to 75 years

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: To be enrolled in this study, participants must meet all the following criteria: 1. Between 45-75 years of age 2. Language Proficiency: participants must be fluent in English or Spanish 3. Have an average risk for colorectal cancer 4. Be a patient at one of our partner FQHCs 5. Received a screening order (either using a stool-based test or colonoscopy) six months ago and failed or refused to complete the screening test 6. Able and willing to provide a blood sample per protocol Exclusion Criteria: Participants will be excluded from enrolling in the study if they meet any of the following: 1. Family history * One first-degree relative diagnosed with CRC or advanced adenoma at age \<60 years * Two first-degree relatives diagnosed with CRC or advanced adenoma at any age * Known hereditary gastrointestinal cancer syndromes, such as Lynch Syndrome or Familial Adenomatous and Polyposis (FAP) 2. Personal History * Participants who do not speak either Spanish or English * History of CRC or adenoma * History of cancers * History of inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease * Have a recorded up to date CRC screening * Blood product transfusion in the past 120 days * A medical condition which, in the opinion of the patient's health provider, should preclude enrollment in the study

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer

As listed by the trial registrant

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

Colo-rectal cancer

Contacts and locations

Locations

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033, United States

More trials for these conditions

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