Radiotherapy Assessments During Intervention ANd Treatment (RADIANT) (RADIANT)

February 6, 2019 updated by: DxTerity Diagnostics
Collect blood samples and associated clinical data prior to, during, and post radiation treatment.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Compton, California, United States, 90220
        • Recruiting
        • DxTerity Diagnostics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Terbrueggen, PhD
    • Florida
      • Bradenton, Florida, United States, 34202
        • Recruiting
        • 21st Century Oncology
        • Principal Investigator:
          • John Sylvester, MD
        • Contact:
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • 21st Century Oncology
        • Principal Investigator:
          • Constantine Mantz, MD
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • 21st Century Oncology
        • Contact:
        • Principal Investigator:
          • Christopher Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DxTerity Diagnostics

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2017

Primary Completion (Anticipated)

September 6, 2019

Study Completion (Anticipated)

September 6, 2019

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DXT-RADTOX-AC03
  • HHSN261201600051C (Other Grant/Funding Number: National Cancer Institute (NCI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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