Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853783
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-05-02
Brief Title:
Evaluation of Oral Potentially Malignant Disorders OPMDs With STRATICYTE
Sponsor:
Proteocyte Diagnostics Inc
Organization:
Proteocyte Diagnostics Inc
Study Overview
Official Title:
Evaluation of Oral Potentially Malignant Disorders OPMDs With STRATICYTE
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
The purpose of this study is to validate the ability of the STRATICYTE predictive model to predict the transformation of oral potentially malignant disorders OPMDs to oral squamous cell carcinoma OSCC in a retrospective cohort of patients who received biopsies
Detailed Description:
The study objectives are to
1 Evaluate STRATICYTE sensitivity and specificity in a cohort of patients that meet the inclusionexclusion criteria
2 Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE model
3 Estimate the correlation between STRATICYTE outcome and time to a positive diagnosis of oral cancer
1 Evaluate STRATICYTE sensitivity and specificity in a cohort of patients that meet the inclusionexclusion criteria
2 Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE model
3 Estimate the correlation between STRATICYTE outcome and time to a positive diagnosis of oral cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None