Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

NCT ID: NCT03133286

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-06

Study Completion Date

2020-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

DxTerity Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

DxTerity Diagnostics

Compton, California, United States

Site Status

21st Century Oncology

Bradenton, Florida, United States

Site Status

21st Century Oncology

Fort Myers, Florida, United States

Site Status

21st Century Oncology

Plantation, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HHSN261201600051C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DXT-RADTOX-AC03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiation Pneumonitis After SBRT for NSCLC
NCT02428049 ACTIVE_NOT_RECRUITING