Cancer, Cancer of Anus, Cancer of Bladder, Cancer of Cervix, Cancer of Colon, Cancer of Esophagus, Cancer of Gallbladder, Cancer of Kidney, Cancer of Kidney and Renal Pelvis, Cancer of Liver, Cancer of Ovary, Cancer of Pancreas, Cancer of Prostate, Cancer of Rectum, Cancer of Stomach, Cancer of Testis, Cancer of Uterus, Cancer of Uterus and Cervix, Radiation Therapy
Conditions
Keywords
Anal Cancer, Bladder, Cervical, Colorectal, Esophageal, Gallbladder, Liver, Ovarian, Pancreas, Pancreatic, Prostate, Rectal, Renal, Kidney, Stomach, Testicular, Uterine, Cancer, Radiation Therapy, Radiation Treatment
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).
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
DxTerity Diagnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients age 18 or older 2. Have a permanent address in the United States for the duration of the study 3. Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer 4. Planned radiation therapy to the abdominal/pelvic area as part of clinical care 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obtain pre- and post-irradiation participant-collect blood samples | 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. |
Countries
United States
Outcome results
None listed