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

• Conditions: Radiation Therapy

• Registration Number: NCT03142425
• Lead Sponsor: DxTerity Diagnostics

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.

Study Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Study Start: 2017-06-19
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

City of Hope; 🇺🇸 Duarte, California, United States

Kaiser Permanente Los Angeles Medical Group; 🇺🇸 Los Angeles, California, United States