Radiotherapy Assessments During Intervention ANd Treatment (RADIANT) (RADIANT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03133286|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 4, 2017
|Condition or disease|
|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 Cancer of Uterus and Cervix Cancer of Kidney|
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; 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).
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)|
|Actual Study Start Date :||April 6, 2017|
|Estimated Primary Completion Date :||September 6, 2018|
|Estimated Study Completion Date :||September 6, 2018|
- Obtain pre- and post-irradiation participant-collect blood samples [ Time Frame: 1.5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133286
|Contact: Lilian N Borisov, BSemail@example.com|
|Contact: Andrea M Aarruda, BSfirstname.lastname@example.org|
|United States, California|
|Compton, California, United States, 90220|
|Contact: Lilian N Borisov, BS 310-537-7857 email@example.com|
|Contact: Andrea M Arruda, BS 310-537-7857 firstname.lastname@example.org|
|Principal Investigator: Robert Terbrueggen, PhD|