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NCT03133286 Clinical Trial

Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Cancer Clinical Trial

— RADIANT  

Official title:
Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03133286
Other study ID # DXT-RADTOX-AC03
Secondary ID HHSN261201600051
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2017
Est. completion date September 6, 2019

Study information
Verified date February 2019
Source DxTerity Diagnostics
Contact Kristen Warren
Phone 310-537-7857
Email kwarren@dxterity.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Collect blood samples and associated clinical data prior to, during, and post radiation treatment.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date September 6, 2019
Est. primary completion date September 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

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

Study Design

Related Conditions & MeSH terms

  • Anus Neoplasms
  • 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
  • Carcinoma, Renal Cell
  • Colonic Neoplasms
  • Esophageal Neoplasms
  • Gallbladder Neoplasms
  • Kidney Neoplasms
  • Liver Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Radiation Therapy
  • Rectal Neoplasms
  • Stomach Neoplasms
  • Testicular Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms

Locations
Country Name City State
United States 21st Century Oncology Bradenton Florida
United States DxTerity Diagnostics Compton California
United States 21st Century Oncology Fort Myers Florida
United States 21st Century Oncology Plantation Florida

Sponsors (2)
Lead Sponsor Collaborator
DxTerity Diagnostics National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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