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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN261201600051C | Other Grant/Funding Number | National Cancer Institute (NCI) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Collect blood samples and associated clinical data prior to, during, and post radiation treatment.
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).
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| Measure | Description | Time Frame |
|---|---|---|
| Obtain pre- and post-irradiation participant-collect blood samples | Obtain pre-irradiation participant-collected blood sample and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care. | 1.5 years |
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Inclusion Criteria:
Exclusion Criteria:
1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
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Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DxTerity Diagnostics | Compton | California | 90220 | United States | ||
| 21st Century Oncology |
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| Bradenton |
| Florida |
| 34202 |
| United States |
| 21st Century Oncology | Fort Myers | Florida | 33908 | United States |
| 21st Century Oncology | Plantation | Florida | 33324 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001005 | Anus Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D008113 | Liver Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| D007680 | Kidney Neoplasms |
| D013274 | Stomach Neoplasms |
| D013736 | Testicular Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D007674 | Kidney Diseases |
| D013272 | Stomach Diseases |
| D013733 | Testicular Diseases |
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