Radiation Therapy
Conditions
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.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
DxTerity Diagnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactAndrea Arruda, B.S.
Backup ContactKristen Warren, B.S.
Outcome results
None listed