Colorectal CarcinomaNCT05716477
Blood Test (Guardant Shield™) for Screening of Colorectal Cancer in Underserved Patients
An observational study of Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the use of a blood test (Guardant Shield™) for colorectal cancer screening. Colorectal cancer is the third leading cancer and cause of death in the United States. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Biospecimen Collection and Survey Administration
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2022to 30 Nov 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.
Who may be able to join
- Women aged 45 years of age and older who are in need of colorectal screening
- Do not have a history of cancer
- Able to read and understand English
- Have a provider to receive the results of the test and who will follow-up test results
- Able to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The Ohio State University Guardant Shield™ Colorectal Cancer Screening Project
This clinical trial evaluates the use of a blood test (Guardant Shield™) for colorectal cancer screening. Colorectal cancer is the third leading cancer and cause of death in the United States. Screening may help doctors find colorectal cancer early when it is easier to treat yet nearly a third of all people eligible for screening have never had a screening test performed. Currently, doctors use a stool- based test such as the fecal immunochemical test (FIT) and visual tests such as a colonoscopy. Blood based testing such as Guardant Shield™, may provide a quick and effective way to screen patients that are hard to reach or with limited access (underserved).
Read the detailed description
PRIMARY OBJECTIVES:
- Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.
II. Obtain data regarding knowledge, attitudes and beliefs about colorectal cancer screening.
OUTLINE:
Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study.
- Conditions
- Colorectal Carcinoma
- Being tested
- Biospecimen Collection, Survey Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Screening (biospecimen collection) | Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study. Receives: Procedure: Biospecimen Collection; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients consented
The number and percentage of patients consented out of those approached to be summarized.
Measured: Up to 2 years
Percentage of patients consented
The number and percentage of patients consented out of those approached to be summarized.
Measured: Up to 2 years
Knowledge about colorectal screening
Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).
Measured: Up to 2 years
Attitudes about colorectal screening
Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).
Measured: Up to 2 years
Beliefs about colorectal screening
Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start23 Dec 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 146 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guardant Health, Inc.
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D Paskett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716477
- Sponsor's protocol ID
- OSU-22204
- Other IDs
- NCI-2023-00078
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ohio State University Guardant Shield™ Colorectal Cancer Screening Project
- ClinicalTrials.gov ID
- NCT05716477
- Acronym / sponsor ID
- OSU-22204
- Conditions
- Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Guardant Health, Inc.
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the use of a blood test (Guardant Shield™) for colorectal cancer screening. Colorectal cancer is the third leading cancer and cause of death in the United States. Screening may help doctors find colorectal cancer early when it is easier to treat yet nearly a third of all people eligible for screening have never had a screening test performed. Currently, doctors use a stool- based test such as the fecal immunochemical test (FIT) and visual tests such as a colonoscopy. Blood based testing such as Guardant Shield™, may provide a quick and effective way to screen patients that are hard to reach or with limited access (underserved).
Detailed description
PRIMARY OBJECTIVES:
- Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.
II. Obtain data regarding knowledge, attitudes and beliefs about colorectal cancer screening.
OUTLINE:
Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Survey AdministrationParticipants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.
Key inclusion criteria (5 listed)
- Women aged 45 years of age and older who are in need of colorectal screening
- Do not have a history of cancer
- Able to read and understand English
- Have a provider to receive the results of the test and who will follow-up test results
- Able to provide informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Screening (biospecimen collection) |
| Survey AdministrationComplete survey | Other | Screening (biospecimen collection) |
Primary outcome
Number of patients consented
Time frame: Up to 2 years
The number and percentage of patients consented out of those approached to be summarized.
Percentage of patients consented
Time frame: Up to 2 years
The number and percentage of patients consented out of those approached to be summarized.
Knowledge about colorectal screening
Time frame: Up to 2 years
Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).
Attitudes about colorectal screening
Time frame: Up to 2 years
Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).
Beliefs about colorectal screening
Time frame: Up to 2 years
Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electra D Paskett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 9 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients consented (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2025.