Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521528
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Clinical Study to Evaluate the Feasibility of Using the Single Patient Classifier as a Prognostic Test in Stage II-III Gastric Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions In this study we evaluated the clinical feasibility of the Single Patient Classifier SPC test a new clinical-grade prognostic assay in stage II-III gastric cancer patients
Detailed Description:
A prospective multicenter study was conducted involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals The SPC test was employed to stratify patients into risk groups and its feasibility and performance were evaluated The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment Furthermore 3-year disease-free survivals of risk groups were analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None