Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:41 PM
Study NCT ID:
NCT06060561
Status:
SUSPENDED
Last Update Posted:
2025-08-29
First Post:
2023-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy
Status:
SUSPENDED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
on hold for analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates genetic testing to improve risk assessment and advance efforts to develop precision management for breast cancer by studying saliva samples for genotyping and evaluate associations with pathologic diagnoses and detailed pathologic and radiologic features.
Detailed Description:
PRIMARY OBJECTIVES:
I. To collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) (and related single nucleotide polymorphisms \[SNPs\]) to final diagnosis of ductal carcinoma in situ (DCIS), invasive breast cancer or benign breast disease (BBD); BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise.
II. To relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries.
III. To relate PRS (and related SNPs) to molecular markers in pathologic lesions and background tissues, including associations with breast cancer (BC) molecular subtypes (e.g., luminal, triple-negative (basal) and human epidermal growth factor receptor 2 \[HER2\] overexpressing) and biomarkers in BBD and lobules.
OUTLINE: This is an observational study.
Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.
I. To collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) (and related single nucleotide polymorphisms \[SNPs\]) to final diagnosis of ductal carcinoma in situ (DCIS), invasive breast cancer or benign breast disease (BBD); BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise.
II. To relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries.
III. To relate PRS (and related SNPs) to molecular markers in pathologic lesions and background tissues, including associations with breast cancer (BC) molecular subtypes (e.g., luminal, triple-negative (basal) and human epidermal growth factor receptor 2 \[HER2\] overexpressing) and biomarkers in BBD and lobules.
OUTLINE: This is an observational study.
Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.
Study Oversight
Has Oversight DMC:
False
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?: