Clinical trial NCT03133286: Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
Official title: Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Therapy
Cancer
Cancer of Anus
Cancer of Bladder
Cancer of Cervix
Cancer of Colon
Cancer of Rectum
Cancer of Esophagus
Cancer of Gallbladder
Cancer of Liver
Cancer of Ovary
Cancer of Pancreas
Cancer of Prostate
Cancer of Kidney and Renal Pelvis
Cancer of Stomach
Cancer of Testis
Cancer of Uterus
Cancer of Uterus and Cervix
Cancer of Kidney
Keywords: Anal Cancer
Bladder
Cervical
Colorectal
Esophageal
Gallbladder
Liver
Ovarian
Pancreas
Pancreatic
Prostate
Rectal
Renal
Kidney
Stomach
Testicular
Uterine
Cancer
Radiation Therapy
Radiation Treatment
Lead sponsor: DxTerity Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.

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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Obtain pre- and post-irradiation participant-collect blood samples
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Compton
country: United States
facility: DxTerity Diagnostics
state: California
city: Bradenton
country: United States
facility: 21st Century Oncology
state: Florida
city: Fort Myers
country: United States
facility: 21st Century Oncology
state: Florida
city: Plantation
country: United States
facility: 21st Century Oncology
state: Florida
Study officials:
References: