Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Completed

• Conditions: Cancer of Bladder; Cancer of Cervix; Cancer of Esophagus; Cancer of Ovary; Cancer of Stomach; Cancer of Testis; Cancer of Uterus and Cervix; Cancer of Anus; Cancer of Gallbladder; Cancer of Pancreas

• Registration Number: NCT03133286
• Lead Sponsor: DxTerity Diagnostics

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).

Study Timeline

• Study Start: 2017-04-06
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtain pre- and post-irradiation participant-collect blood samples	1.5 years	Obtain pre-irradiation participant-collected blood sample and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.

Trial Locations

Locations (2)

DxTerity Diagnostics; 🇺🇸 Compton, California, United States

21st Century Oncology; 🇺🇸 Plantation, Florida, United States