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BRIEF TITLE: Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)


  • Org Study ID: DXT-RADTOX-AC03
  • Secondary ID: HHSN261201600051C
  • NCT ID: NCT03133286
  • NCT Alias:
  • Sponsor: DxTerity Diagnostics - Industry
  • Source: DxTerity Diagnostics

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, 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).

Overal Status Start Date Phase Study Type
Recruiting April 6, 2017 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Obtain pre- and post-irradiation participant-collect blood samples

Primary Outcome 1 - Time Frame: 1.5 years

Condition:

  • 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

Eligibility

Criteria:
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. Have an email address and access to the internet for the duration of the study
<br/> 4. Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological
(GYN) cancer

5. Planned radiation therapy to the abdominal/pelvic area as part of clinical care

6. 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Kristen Warren

Phone: 310-537-7857

Email: kwarren@dxterity.com

Location

Facility Status Contact
DxTerity Diagnostics
Compton, California 90220
United States
Recruiting Kristen Warren
310-537-7857
kwarren@dxterity.com