PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02732171|
Recruitment Status : Recruiting
First Posted : April 8, 2016
Last Update Posted : September 17, 2020
This is a single center, prospective cross-sectional study of women who have completed therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for relapse.
Patients will undergo screening bone marrow aspirate to test for presence of disseminated tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Plasma/Buffy Coat Other: Serum Other: Bone Marrow Aspirate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2026|
Screening Bone Marrow Aspirate
All patients will undergo screening bone marrow aspirate to test for disseminated tumor cells (DTCs).
Other: Plasma/Buffy Coat
3 x 10ml EDTA Tube
1 x 8.5ml Serum Separator Tube
Other: Bone Marrow Aspirate
1 x 10ml EDTA Tube
- Number of disseminated tumor cells [ Time Frame: 3 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732171
|Contact: Angela DeMichele, MD||855-216-0098||PennCancerTrials@emergingmed.com|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Angela DeMichele, MD 855-216-0098 PennCancerTrials@emergingmed.com|
|Principal Investigator:||Angela DeMichele, MD||Abramson Cancer Center of the University of Pennsylvania|