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

DxTerity

Status: Unknown

Conditions: Radiation Therapy

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT03142425

DXT-RADTOX-AC02

261201600051C-0-0-1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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