Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
Undergo germline testing
PROCEDURELiquid Biopsy
Undergo liquid biopsy testing
PROCEDUREMagnetic Resonance Imaging of the Whole Body without Contrast
Undergo whole body MRI without contrast
OTHERSurvey Administration
Complete surveys
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>= 50 years, or age within 10 years of first degree relative with cancer at age of diagnosis (as long as age is \>= 18) * Have a strong family history of cancer ( \>= 2 first-degree relatives with cancer, one first and second degree relative with cancer in one lineage (side of family), or at least three first or second degree relatives with cancer in one lineage (side of the family). Non-melanoma skin cancer excluded from family history eligibility * Have a family history of early-onset cancer (age \>40) in at least one first-degree relative * Willing to have 50 mL of blood (approximately 3.5 tablespoons) drawn (40 ml if germline testing already performed) * Able to undergo MRI (no implants, metal, or claustrophobia that would preclude MRI) * Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer * Positron emission tomography/computed tomography (PET/CT) or other whole body imaging modality (including combination of CT chest and abdomen) within 3 years * No signs/symptoms of possible cancer (e.g. hemoptysis, breast mass, blood per rectum, unexplained weight loss) * Willing to undergo standard of care genetic counseling and germline testing, or has already undergone genetic counseling and germline testing * Documented informed consent of the participant
Exclusion criteria
* Unable to provide informed consent * Contraindications to MRI (implants, metal, or claustrophobia that would preclude MRI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM) | Up to 6 months after 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress (Germline testing)A | Up to 6 months after WBM | The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
| Psychological distress (Germline testing)B | Up to 6 months after WBM | The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
| Psychological distress (Liquid Biopsy)A | Up to 6 months after WBM | The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
| Psychological distress (Liquid Biopsy)B | Up to 6 months after WBM | The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
| Psychological distress (WBM)A | Up to 6 months after WBM | The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
| Prevalence of WBM findings requiring additional imaging or invasive testing | Up to 6 months after WBM | Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage. |
| Health Related Quality of Life (HRQOL/Germline) | Up to 6 months after WBM | The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
| Health Related Quality of Life (HRQOL/LB) | Up to 6 months after WBM | The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
| Health Related Quality of Life (HRQOL/WBM) | Up to 6 months after WBM | The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
| Psychological distress (WBM)B | Up to 6 months after WBM | The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between high-risk liquid biopsy findings and cancer detected on WBM | Up to 6 months after 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. |
Countries
United States
Outcome results
None listed