Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
2 other identifiers
observational
150
1 country
2
Brief Summary
Collect blood samples and associated clinical data prior to and post radiation treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 7, 2019
February 1, 2019
2.5 years
April 25, 2017
February 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
Male and female patients, age 18 or older, diagnosed with a primary rectal or esophageal/gastroesophageal junction cancer undergoing radiation therapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DxTerity Diagnosticslead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
City of Hope
Duarte, California, 91010, United States
Kaiser Permanente Los Angeles Medical Group
Los Angeles, California, 90027, United States
Study Officials
- STUDY DIRECTOR
Robert Terbrueggen, PhD
President and CEO
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2017
First Posted
May 5, 2017
Study Start
June 19, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 7, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share