Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945290
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-07-06
Brief Title:
Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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 study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid ctDNA analysis in breast cancer that not spread beyond the breast and or lymph nodes early and locally advanced ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma Pre-analytical factors such as blood collection tubes delays in separation of plasma centrifugation speeds storage conditions shipping and DNA extraction methods can all affect ctDNA measurements Inappropriate processing can cause breaking down of the membrane lysis of peripheral blood cells that release background wild-type DNA and may also cause degradation of circulating tumor-specific DNA fragments Both mechanisms will dilute levels of ctDNA in plasma and make it more difficult to detect Evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collectionprocessing and long-term storage from patients with locally advanced breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the impact of blood collectionprocessing II To evaluate the impact of long-term storage of plasma and extracted DNA
OUTLINE This is an observational study
Patients undergo blood sample collection throughout the study Patients also undergo collection of leftover tissue samples from standard of care SOC procedures and have medical records reviewed
I To evaluate the impact of blood collectionprocessing II To evaluate the impact of long-term storage of plasma and extracted DNA
OUTLINE This is an observational study
Patients undergo blood sample collection throughout the study Patients also undergo collection of leftover tissue samples from standard of care SOC procedures and have medical records reviewed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-05844 | REGISTRY | None | None |
| 19-012665 | OTHER | None | None |
| UH2CA234306 | NIH | None | None |
| U01CA243078 | NIH | Mayo Clinic in Arizona | httpsreporternihgovquickSearchU01CA243078 |