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Determination of Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict GI Radiation Toxicity

NCT04580667 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-08-28

No results posted yet for this study

Summary

This clinical study is conducted to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications, especially related to gastrolintestinal (GI) toxicities. This clinical study would allow monitoring of total tissue damage in blood samples as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy, which could help clinicians make treatment decisions. Detection of excessive tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions which could include patient therapies that would reduce or prevent the problems that occur due to radiotherapy of their cancer.

Conditions

Interventions

OTHER

Collection of plasma samples

Collection of plasma samples - Plasma samples are collected at different times during the study for the RadTox test.

Sponsors & Collaborators

  • DiaCarta, Inc.

    lead INDUSTRY

Principal Investigators

  • Ann K Vallerga, PhD, MBA · DiaCarta, Inc.

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-09-06
Completion
2023-09-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580667 on ClinicalTrials.gov