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Can a new blood test spot colorectal cancer return earlier?

NCT ID NCT07125729

Diagnosis Sponsor: City of Hope Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial compares two blood tests—Haystack and Signatera—that look for tiny traces of tumor DNA in the blood after surgery for stage II-IV colorectal cancer. The goal is to see which test is better at detecting minimal residual disease, which could signal that cancer may come back. Adults with resectable colorectal cancer who have had or will have curative surgery are eligible. The study measures how accurately each test predicts recurrence and how early they detect it compared to standard imaging.

What this could mean

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

Active substance
Blood-based minimal residual disease (MRD) testing using the Haystack assay compared to the Signatera assay
What this could lead to
If Haystack proves more sensitive, it could enable earlier detection of colorectal cancer recurrence after surgery, potentially improving chances of curative treatment.
What could go wrong
This is an early comparison study, not a treatment trial. The Haystack test may not outperform Signatera in real-world settings, and results may not change 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

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

Started

Aug 2025

Expected to finish

Jan 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.

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: * Documented written informed consent of the participant * Age: ≥ 18 years * Diagnosis of stage II, III or IV colorectal cancer (any gender) if enrolled post-operatively. If a treatment naïve patient is enrolled pre-operatively and determined to be pathological stage I, the patient will be replaced * Patient who are to undergo a curative intent surgery or have undergone a curative resection and are presenting for surveillance * Patient identified as an appropriate candidate for Signatera® testing as a standard of care MRD surveillance assay * Patient willingness to continue Signatera® assay every 3 months for 2 years in the first 2 years after resection and every 6 months for years 3, 4, 5 after resection, as performed by standard of care testing. In addition, the patients should be willing to provide blood samples for Haystack MRD testing at the same intervals of Signatera®, along with willingness to allow access to archival tissue to allow for Haystack MRD assay personalization. Surveillance with ctDNA should be initiated between 3 to 10 weeks from surgery * Adequate availability of archival tissue or anticipated pathological viable tissue. All untreated primary resection would be expected to have adequate tissue. Patients with resected metastatic disease should have either previously resected primary that is amenable for tumor informed MRD testing or should have adequate archival metastasectomy samples * Patients with total neoadjuvant therapy (TNT) for rectal cancer and complete clinical response with plans of watchful waiting may also be enrolled as long as there is adequate tissue from prior endoscopic biopsies to allow for Signatera® and Haystack MRD assays Exclusion Criteria: * Inability to safely provide sequential blood samples * Clinical evidence of unresected metastatic disease * Inability to give informed consent

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

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

Resectable colorectal carcinoma Stage II colorectal cancer ajcc V8 Stage III colorectal cancer ajcc V8 Stage IV colorectal cancer ajcc V8

How to take part

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

  1. The places running it

    13 sites. 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

  • CTCA at Western Regional Medical Center

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • City of Hope Antelope Valley

    RECRUITING

    Lancaster, California, 93534, United States

  • City of Hope Atlanta Cancer Center

    RECRUITING

    Newnan, Georgia, 30265, United States

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope Corona

    RECRUITING

    Corona, California, 92882, United States

  • City of Hope Seacliff

    RECRUITING

    Huntington Beach, California, 92648, United States

  • City of Hope South Bay

    RECRUITING

    Torrance, California, 90503, United States

  • City of Hope South Pasadena

    RECRUITING

    South Pasadena, California, 91030, United States

  • City of Hope Upland

    RECRUITING

    Upland, California, 91786, United States

  • City of Hope at Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • City of Hope at Irvine Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope at Long Beach Elm

    RECRUITING

    Long Beach, California, 90813, United States

  • City of Hope at Newport Beach Fashion Island

    RECRUITING

    Newport Beach, California, 92660, United States

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