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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01829 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21574 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study evaluates patient acceptability of whole body magnetic resonance imaging (WBM) and liquid biopsies (LB) in detecting early stage cancer in patients with a strong family history of cancer. Collecting family history and testing for genes passed on from parent to child (germline testing) can be used to predict the likelihood of a patient developing cancer. Currently, detection of early cancers focuses on screening specific organ systems such as breast and colon cancer. Magnetic resonance imaging (MRI) uses a large magnet and radio waves to look at organs and structures inside the body. Health care professionals use MRI scans to diagnose a variety of conditions, from torn ligaments to cancer. Liquid biopsy is test that analyzes blood samples to determine if cancer cells are present. This study may help researchers determine the feasibility of WBM and liquid biopsies to detect early stage cancer in patients that have a strong family history of cancer.
PRIMARY OBJECTIVE:
I. To assess the acceptability of the approach of LB and WBM.
SECONDARY OBJECTIVES:
I. Determine the prevalence of WBM findings requiring additional imaging or invasive testing.
II. Determine the effect of germline testing, LB, and WBM on psychological distress and health-related quality of life (HR-QOL) at 6 months after testing compared with baseline.
EXPLORATORY OBJECTIVE:
I. Determine correlation between high-risk LB findings and cancer detected on WBM.
OUTLINE: This is an observational study.
Patients undergo WBM without contrast, blood sample collection for liquid biopsy, and complete surveys on study. Germline testing may also be performed on blood sample collected as standard of care or using the Precision Medicine protocol (Institutional Review Board [IRB] 96144).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Body MRI and Liquid Biopsy | Experimental | Patients undergo WBM without contrast and blood sample collection for liquid biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM) | Acceptability, as measured by the survey question "How satisfied are you with the research study overall?" and is defined as a score of 4 ("moderately acceptable) or 5 ("highly acceptable"). | Up to 6 months after WBM |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of WBM findings requiring additional imaging or invasive testing | Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage. | Up to 6 months after WBM |
| Psychological distress (Germline testing)A |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between high-risk liquid biopsy findings and cancer detected on WBM | Liquid biopsy (LB) test sensitivity and specificity calculated by comparing the LB results with the WBM results, with WBM results considered the gold standard. Confusion matrix statistics, such as positive predictive value, negative predictive value, and test accuracy examined. Results reported with their corresponding 95% confidence intervals. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Raz | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39748640 | Derived | Raz DJ, Nehoray B, Ceniceros A, Motarjem P, Landau S, Nelson RA, Gray SW. Feasibility of a cancer screening program using multicancer early detection testing and whole-body magnetic resonance imaging in a high-risk population. Cancer. 2025 Jan 1;131(1):e35709. doi: 10.1002/cncr.35709. |
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| Genetic Testing for Cancer Risk | Genetic | Undergo germline testing |
|
|
| Liquid Biopsy | Procedure | Undergo liquid biopsy testing |
|
|
| Magnetic Resonance Imaging of the Whole Body without Contrast | Procedure | Undergo whole body MRI without contrast |
|
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| Survey Administration | Other | Complete surveys |
|
The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
| Up to 6 months after WBM |
| Psychological distress (Germline testing)B | The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. | Up to 6 months after WBM |
| Psychological distress (Liquid Biopsy)A | The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. | Up to 6 months after WBM |
| Psychological distress (Liquid Biopsy)B | The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. | Up to 6 months after WBM |
| Psychological distress (WBM)A | The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. | Up to 6 months after WBM |
| Psychological distress (WBM)B | The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. | Up to 6 months after WBM |
| Health Related Quality of Life (HRQOL/Germline) | The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. | Up to 6 months after WBM |
| Health Related Quality of Life (HRQOL/LB) | The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. | Up to 6 months after WBM |
| Health Related Quality of Life (HRQOL/WBM) | The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. | Up to 6 months after WBM |
| Up to 6 months after WBM |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D005820 | Genetic Testing |
| D003376 | Counseling |
| D000073890 | Liquid Biopsy |
| D003287 | Contrast Media |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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