Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Sponsor

DxTerity Diagnostics (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03133286

Collaborator

National Cancer Institute (NCI) (NIH)

500

Enrollment

Locations

Anticipated Duration (Months)

125

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

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, during, and 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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Actual Study Start Date :

Apr 6, 2017

Anticipated Primary Completion Date :

Sep 6, 2019

Anticipated Study Completion Date :

Sep 6, 2019

Outcome Measures

Primary Outcome Measures

Obtain pre- and post-irradiation participant-collect blood samples [1.5 years]
Obtain pre-irradiation participant-collected blood samples as well subsequent 3 participant-collected blood samples and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DxTerity Diagnostics	Compton	California	United States	90220
2	21st Century Oncology	Bradenton	Florida	United States	34202
3	21st Century Oncology	Fort Myers	Florida	United States	33908
4	21st Century Oncology	Plantation	Florida	United States	33324