Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-15 @ 10:39 PM
Study NCT ID:
NCT02577627
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC
Sponsor:
Optimata Ltd.
Organization:
Study Overview
Official Title:
Multi-Centre, Multi-Indication, Two-Stage, Oncological Study to Retrospectively Assess and Prospectively Validate the Predictive Accuracy of PrediCare - a Standalone, Treatment Decision Support Software Device for Predicting Time-to-Progression in Individual Patients Under Standard of Care Treatments
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective observational, open label study to evaluate and prospectively validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Castration-Resistant Prostate Cancer, Breast Cancer \& Colon Cancer under the treatment with the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the market as a Standard of Care
Detailed Description:
The goals of this study are assessing and validating the accuracy of the PrediCare predictions by comparing them to the actual patients outcome. Study population will be composed of patients diagnosed with advanced stage disease, and divided according to the indications and treatment protocols. Retrospective data collected from patients' files will enable Optimata to compare the PrediCare Technology predictions of the pattern of metastatic and primary tumor growth and dynamics of oncological markers over time with the actual outcomes in each individual patient.
Study Oversight
Has Oversight DMC:
False
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?: