Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-27 @ 2:04 PM
Study NCT ID:
NCT04580667
Status:
WITHDRAWN
Last Update Posted:
2025-08-28
First Post:
2020-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict GI Radiation Toxicity
Sponsor:
DiaCarta, Inc.
Organization:
Study Overview
Official Title:
Prospective Observational Exploratory Clinical Study to Determine the Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict Gastrointestinal Radiation Toxicity Using Circulating Cell Free DNA Directly From Plasma
Status:
WITHDRAWN
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor declared bankruptcy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) doses are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy and should help identify patients at high risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity, especially gastrointestinal toxicities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: