Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

DxTerity

Status: Completed

Conditions: Cancer of Rectum; Radiation Therapy; Cancer of Colon; Cancer of Uterus; Cancer of Testis; Cancer of Gallbladder; Cancer of Ovary; Cancer of Liver; Cancer of Esophagus; Cancer; Cancer of Bladder; Cancer of Uterus and Cervix; Cancer of Pancreas; Cancer of Anus; Cancer of Kidney and Renal Pelvis; Cancer of Prostate; Cancer of Cervix; Cancer of Kidney; Cancer of Stomach

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT03133286

HHSN261201600051C (Other Grant/Funding Number)

DXT-RADTOX-AC03

Details and patient eligibility

About

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

Full description

In order to further refine and independently validate the performance of DxTerity's test developed during the previous pilot study, the study will collect pre-, during, and post-irradiation blood samples and associated clinical and self-reported information from up to five hundred (500) subjects for analysis. Patients with a diagnosis of primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer requiring radiation treatment to the primary disease site will be included in the study. Combining chemotherapy is allowed.

Blood samples for this study will be collected from cancer patients scheduled to undergo radiation therapy prior to and either during or after treatment. Approximately 150μL of blood per time point will be obtained via fingerstick remotely, from the participant's home or doctor's office; participation in this study will not affect any aspect of patient treatment. Samples will be collected using DxTerity's proprietary DxCollect® MCD Fingerstick Kit (MCD).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients age 18 or older
2. Have a permanent address in the United States for the duration of the study
3. Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
4. Planned radiation therapy to the abdominal/pelvic area as part of clinical care
5. Able to provide informed consent

Exclusion criteria

1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment