Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy

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

Study Overview

• Status: Unknown
• Conditions: Radiation Therapy

Detailed Description

Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Andrea Arruda, B.S.; Phone Number: 310-537-7857; Email: aarruda@dxterity.com
• Study Contact Backup: Name: Kristen Warren, B.S.; Phone Number: 310-537-7857; Email: kwarren@dxterity.com

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Contact: Bianca Del Vecchio; Phone Number: 64402 626-256-4673; Email: bdelvecchio@coh.org
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Kaiser Permanente Los Angeles Medical Group
      • Contact: Jennifer Keyte; Phone Number: 323-783-5071; Email: jennifer.n.keyte@kp.org
      • Principal Investigator: Michael R. Girvigian, MD

Participation Criteria

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

Male and female patients, age 18 or older, diagnosed with a primary rectal or esophageal/gastroesophageal junction cancer undergoing radiation therapy.

Description

Inclusion Criteria:

1. Male and female patients age 18 or older
2. Diagnosed with a primary rectal or esophageal cancer
3. Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care
4. Combining chemotherapy is allowed
5. ECOG Performance Status 0-2
6. Able to provide written informed consent

Exclusion Criteria:

1. Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
2. Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study

Study Plan

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
Collection of blood samples from patients prior to and post irradiation treatment.	Explore and validate a radiation sensitivity test for determining radiation treatment tumor response by refining and analyzing gene expression signature of blood samples collected from 150 patients prior to and post irradiation treatment.	Up to 4 months, from informed consent through follow up activities.

Collaborators and Investigators

• Sponsor: DxTerity Diagnostics
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Director: Robert Terbrueggen, PhD, President and CEO

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DXT-RADTOX-AC02; 261201600051C-0-0-1 (U.S. NIH Grant/Contract)

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