Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiation Therapy
- Sponsor
- DxTerity Diagnostics
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Obtain pre- and post-irradiation participant-collect blood samples
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Collect blood samples and associated clinical data prior to, during, and post radiation treatment.
Detailed Description
In order to further refine and independently validate the performance of DxTerity's test developed during the previous pilot study, the study will collect pre-, during, and post-irradiation blood samples and associated clinical and self-reported information from up to five hundred (500) subjects for analysis. Patients with a diagnosis of primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer requiring radiation treatment to the primary disease site will be included in the study. Combining chemotherapy is allowed. Blood samples for this study will be collected from cancer patients scheduled to undergo radiation therapy prior to and either during or after treatment. Approximately 150μL of blood per time point will be obtained via fingerstick remotely, from the participant's home or doctor's office; participation in this study will not affect any aspect of patient treatment. Samples will be collected using DxTerity's proprietary DxCollect® MCD Fingerstick Kit (MCD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients age 18 or older
- •Have a permanent address in the United States for the duration of the study
- •Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
- •Planned radiation therapy to the abdominal/pelvic area as part of clinical care
- •Able to provide informed consent
Exclusion Criteria
- •Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
Outcomes
Primary Outcomes
Obtain pre- and post-irradiation participant-collect blood samples
Time Frame: 1.5 years
Obtain pre-irradiation participant-collected blood sample and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.