Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434337
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-23
Brief Title:
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus HPV
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus HPV
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To learn if new HPV tests can provide the same results as standard HPV tests The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible
Detailed Description:
Primary Objectives
1 To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV Rice HPV test
Secondary Objectives
1 To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia CIN 2
2 To assess how different sample processing methods affect the performance of the Rice HPV test
3 To assess how different test readout methods affect the performance of the Rice HPV test
Exploratory Objectives
1 Compare the performance of the Rice HPV test between provider-collected and self-collected samples
2 Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling
3 Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert
1 To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV Rice HPV test
Secondary Objectives
1 To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia CIN 2
2 To assess how different sample processing methods affect the performance of the Rice HPV test
3 To assess how different test readout methods affect the performance of the Rice HPV test
Exploratory Objectives
1 Compare the performance of the Rice HPV test between provider-collected and self-collected samples
2 Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling
3 Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04598 | OTHER | NCI-CTRP Clinical Registry | None |