Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Study Overview
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Brief Summary
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Collect blood samples and associated clinical data prior to, during, and post radiation treatment.

Detailed Description
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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, during, and 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).

Official Title
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Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Conditions
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Cancer of Uterus and Cervix, Cancer of Kidney, Radiation Therapy, Cancer, Cancer of Anus, Cancer of Bladder, Cancer of Cervix, Cancer of Colon, Cancer of Rectum, Cancer of Esophagus, Cancer of Gallbladder, Cancer of Liver, Cancer of Ovary, Cancer of Pancreas, Cancer of Prostate, Cancer of Kidney and Renal Pelvis, Cancer of Stomach, Cancer of Testis, Cancer of Uterus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients age 18 or older Have a permanent address in the United States for the duration of the study Have an email address and access to the internet 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: 1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain pre- and post-irradiation participant-collect blood samples | Obtain pre-irradiation participant-collected blood samples as well subsequent 3 participant-collected blood samples and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care. | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder, Stomach, Testicular, Anal Cancer, Cervical, Colorectal, Esophageal, Gallbladder, Liver, Ovarian, Pancreas, Pancreatic, Prostate, Rectal, Renal, Kidney, Uterine, Cancer, Radiation Therapy, Radiation Treatment