AzTrials
AzTrials

Colorectal Cancer (Diagnosis)CLEARNCT07479381

Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study

An observational study of Colorectal Cancer (Diagnosis), run by Harbinger Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC). Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Colorectal Cancer (Diagnosis)
How many people
14 participants
Where
1 siteUnited States
Study dates
20 Mar 2026to 27 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants 45 years of age or older with: average risk colorectal cancer (CRC) and a positive result on a multitarget stool DNA test, and participants with a confirmed CRC diagnosis.

Who may be able to join

  • Cohort 1: Prospective Cohort Inclusion criteria - All Participants must meet the following criteria to be included in the study:
  • Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
  • Age 45 or older at time of consent
  • Documented positive result from a mt-sDNA test obtained as part of routine clinical care within 12 months of blood draw
  • Scheduled and intends to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care
  • Considered by a physician as being of average risk for CRC
Show all 12Show fewer
  • Willing to provide an investigational blood draw prior to undergoing bowel preparation administration and colonoscopy.
  • Cohort 2: Confirmed Case Cohort Inclusion criteria - All Participants must meet the following criteria to be included in the study:
  • Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
  • Age 45 or older at time of consent
  • Has a confirmed CRC diagnosis within 90 days prior to signing the informed consent form, based on standard diagnostic procedures
  • Must remain treatment-naïve for the current malignancy (no surgical resection, neoadjuvant chemotherapy, or radiation therapy has occurred since diagnosis)

Who cannot join

  • Cohort 1: Prospective Cohort Exclusion Criteria - Participants who meet any of the following criteria will be excluded from study entry:
  • Undergoing colonoscopy for investigation of symptoms such as rectal bleeding, blood in stool, or significant recent changes in stool habits
  • History of CRC or AA diagnosed prior to the index mtsDNA positive test result
  • History of any malignancy (patients who have undergone surgical removal of skin basal cell or squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of informed consent)
  • Has been diagnosed with a condition associated with a high risk of CRC (including inflammatory bowel disease (IBD), chronic ulcerative colitis, Crohn's disease, or familial adenomatous polyposis) or has a family history of CRC, defined as having a first-degree relative (parent, sibling, or child) with a CRC diagnosis at any age
  • Has been diagnosed with a relevant familial (hereditary) cancer syndrome that places them above average risk of CRC such as hereditary nonpolyposis CRC syndrome (or Lynch syndrome), Peutz-Jeghers syndrome, MYH-associated polyposis, Gardner's syndrome, Turcot's (or Crail's) syndrome, Cowden's syndrome, juvenile polyposis, Cronkhite-Canada syndrome, neurofibromatosis, or familial hyperplastic polyposis
Show all 22Show fewer
  • Is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours preceding the blood draw
  • Participant is pregnant (self-reported)
  • Recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Participants with a corneal transplant can be considered for study entry)
  • Inability or unwillingness to comply with study procedures or follow-up requirements
  • Previous or current participation in any study sponsored by, or employment with, Harbinger Health
  • Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
  • Has any condition that in the opinion of the Investigator should preclude participation in the study
  • Cohort 2: Confirmed Case Cohort Exclusion Criteria - Participants who meet any of the following criteria will be excluded from study entry:
  • Has a history of any malignancy (patients who have undergone surgical removal of skin basal cell or squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of informed consent for the study)
  • Is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours preceding the blood draw
  • Participant is pregnant (self-reported)
  • Is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Participants with a corneal transplant can be considered for study entry)
  • Inability or unwillingness to comply with study procedures or follow-up requirements
  • Previous or current participation in any study sponsored by, or employment with, Harbinger Health
  • Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
  • Has any condition that in the opinion of the Investigator should preclude participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Aton Health

    Kansas City, Missouri, 64114

Other trials in United States

About this study

Official title: Pilot Study to Evaluate a Blood Based Test to Prioritize Diagnostic Colonoscopy Following a Positive Colorectal Cancer Screening Test (CLEAR Study)

The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC).

Read the detailed description

Participants 45 years and older who are at average risk for colorectal cancer (CRC) with a positive multitarget stool DNA (mt-sDNA) screening test result and scheduled to undergo diagnostic colonoscopy as part of standard clinical care within 60 days of providing informed consent (Cohort 1), and participants with confirmed CRC diagnosed within 90 days prior to providing informed consent, based on standard diagnostic procedures (Cohort 2), will be enrolled. Participants enrolled with confirmed CRC must be treatment-naïve at the time of enrollment. A one-time blood sample will be collected from all enrolled participants within 14 days of signing the informed consent form. Participation will be completed when the participant completes the blood draw, and after the participant's cancer status is established (at enrollment for those enrolled with confirmed CRC (Cohort 2), and by 60 days post-colonoscopy for those in the prospective cohort (Cohort 1)). Participants in Cohort 1 may be directly contacted after enrollment if diagnosis details are not available in the medical records. It is expected that study enrollment will take approximately 12 months. Results generated from study samples are investigational and will not be returned to investigators, study participants, or participants' healthcare providers, and will not be used for clinical decision-making.

Keywords
Colorectal cancer, Cancer, Diagnostic test, Blood test, Oncology
Medical subject headings
Colorectal Neoplasms, Disease, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07479381
Study groupRoleWhat they receive
Cohort 1: Prospective CohortParticipants with average risk CRC and a positive mt-sDNA test within 12 months of the study blood draw and who are scheduled and intending to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care.
Cohort 2: Confirmed Case CohortParticipants with a confirmed colorectal cancer diagnosis at informed consent and who are treatment-naïve for the current malignancy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establish predictive value

    1. Establish the predictive value of the Harbinger test for colorectal cancer (CRC) per test readout category.

    Measured: 14 month

Secondary outcomes (2)

  1. Establish incidence

    Establish the incidence of CRC (by stage) and advanced adenoma (AA)

    Measured: 14 months

  2. Establish readout distribution

    Establish the readout distribution of the Harbinger test for CRC cases (by stage), AA cases, and Participants without CRC or AA.

    Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start20 Mar 2026
  3. Primary completion27 Mar 2026
  4. Study completion27 Mar 2026

Why it stopped: Study terminated per sponsor decision due to operational reasons. The termination was not a result of any participant safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07479381
Sponsor's protocol ID
HH-PRT-0006
Acronym
CLEAR
Status last verified
Apr 2026
First submitted
10 Mar 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer (Diagnosis), run by Harbinger Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study terminated per sponsor decision due to operational reasons. The termination was not a result of any participant safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish predictive value (time frame: 14 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07479381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in