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

Radiation Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142425
• Other study ID #: DXT-RADTOX-AC02
• Secondary ID: 261201600051C-0-
• Status: Recruiting
• Start date: June 19, 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: DxTerity Diagnostics
• Contact: Andrea Arruda, B.S.
• Phone: 310-537-7857
• Email: aarruda[@]dxterity.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiation Therapy

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	Kaiser Permanente Los Angeles Medical Group	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
DxTerity Diagnostics	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.