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Blood test may spot hidden cancer DNA after surgery

NCT ID NCT05210283

Knowledge-focused Sponsor: Exact Sciences Corporation 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a blood test that looks for tiny bits of cancer DNA in the blood after colorectal cancer surgery. The goal is to see if this test can predict whether the cancer will return. Over 1,000 people with stage II or III colorectal cancer will be followed for up to 7 years. The test is not a treatment, but a way to monitor for recurrence.

What this could mean

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

Active substance
ctDNA MRD test (blood test)
What this could lead to
If successful, this blood test could help doctors identify which patients are at risk of cancer returning after surgery, allowing for earlier treatment.
What could go wrong
This is a validation study, not a treatment trial. The test may not be accurate enough to change outcomes, 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

1,017 people

The number who actually took part.

Started

Dec 2021

Expected to finish

May 2027

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

Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer

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: 1. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible). 2. Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met: 1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and 2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells. i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized. 3. Pathologic stage II or III 4. ECOG performance status ≤ 2 (0, 1 or 2). 5. Able to understand and provide informed consent. 6. Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw. Exclusion Criteria: 1. Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable). 2. Pregnant or breastfeeding at time of enrollment. 3. Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment. 4. Prior transplant history: 1. Prior allogeneic hematopoietic stem cell transplant at any time. 2. Prior solid organ transplant within the last 2 years prior to enrollment. 5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Colorectal cancer

Contacts and locations

Locations

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Ballad Health Cancer Center

    Kingsport, Tennessee, 37660, United States

  • Columbus NCORP

    Columbus, Ohio, 43215, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G1Z2, Canada

  • Edward Cancer Center

    Elmhurst, Illinois, 60126, United States

  • Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology

    Mission Hills, California, 91345, United States

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374, United States

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Interstate Medical Office Central

    Portland, Oregon, 97227, United States

  • Jewish General Hospital

    Montreal, Quebec, H3T1E2, Canada

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Marshfield Medical Center Weston

    Weston, Wisconsin, 54476, United States

  • McGill University Health - Glen Site

    Montreal, Quebec, H4A3J1, Canada

  • MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital

    Baltimore, Maryland, 21237, United States

  • Mercy Medical Center

    Cedar Rapids, Iowa, 52403, United States

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742, United States

  • Metro Minnesota Community Oncology Consortium (MMCORC)

    Saint Louis Park, Minnesota, 55426, United States

  • Mid Florida Cancer Centers

    Orange City, Florida, 32763, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Mount Sinai Medical - Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • Primsa Health Cancer Institute

    Greenville, South Carolina, 29605, United States

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G2C1, Canada

  • Reading Hospital Hematology Oncology

    West Reading, Pennsylvania, 19611, United States

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58104, United States

  • Torrance Memorial Hunt Cancer Institute

    Torrance, California, 90505, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Florida Division of Hematology & Oncology

    Gainesville, Florida, 32610, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Maryland St. Joseph Medical Center

    Towson, Maryland, 21093, United States

  • WellSpan York Cancer Center

    York, Pennsylvania, 17403, United States

More trials for these conditions

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