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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-00078 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Guardant Health, Inc. | INDUSTRY |
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This clinical trial evaluates the use of a blood test (Guardant Shieldâ„¢) 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 Shieldâ„¢, may provide a quick and effective way to screen patients that are hard to reach or with limited access (underserved).
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (biospecimen collection) | Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients consented | The number and percentage of patients consented out of those approached to be summarized. | Up to 2 years |
| Percentage of patients consented | The number and percentage of patients consented out of those approached to be summarized. | 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.). | 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.). | 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.). | Up to 2 years |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Electra D Paskett, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Survey Administration | Other | Complete survey |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |