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

DxTerity Diagnostics2 sites in 1 country150 target enrollmentJune 19, 2017

ConditionsRadiation Therapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Radiation Therapy
Sponsor: DxTerity Diagnostics
Enrollment: 150
Locations: 2
Primary Endpoint: Collection of blood samples from patients prior to and post irradiation treatment.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 19, 2017

End Date

December 2019

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

DxTerity Diagnostics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female patients age 18 or older
•Diagnosed with a primary rectal or esophageal cancer
•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
•Combining chemotherapy is allowed
•ECOG Performance Status 0-2
•Able to provide written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Collection of blood samples from patients prior to and post irradiation treatment.

Time Frame: Up to 4 months, from informed consent through follow up activities.

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.