Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 2:51 PM
Study NCT ID:
NCT03715959
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2018-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nipple Aspirate Fluid in Detecting Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
Status:
COMPLETED
Status Verified Date:
2025-02
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:
This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.
Detailed Description:
PRIMARY OBJECTIVES:
I. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.
II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.
OUTLINE:
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
After completion of study, participants are followed up at 1 year.
I. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.
II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.
OUTLINE:
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
After completion of study, participants are followed up at 1 year.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01437 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |