The Immune System's Response to Young Women's Breast Cancer
NCT ID: NCT01503190
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2009-07-21
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological confirmation of breast cancer.
3. For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides should be available or planned to be available after upcoming procedure.
4. Patient should be willing to have fresh and/or fresh frozen tissue collected at time of core biopsy, definitive breast cancer surgery or clinically planned breast cancer metastasis biopsy/resection for research purposes as part of study procedures, if a procedure is in the future planning of the patient's treatment.
5. Any clinical stage allowed.
6. Written informed consent obtained prior to any initiation of study procedures in the case of subjects consented in clinic. Subjects consented outside of UCH, VVMC or SCC will be consented by phone and verbal informed consent will be obtained prior to any initiation of study procedures.
7. Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.
8. Women who have commenced or completed their breast cancer treatment may join this study by consenting to a retrospective tissue donation only consent of the protocol.
9. Women who receive their care at a facility other than UCH, VVMC or SCC may join this study. These women will be consented utilizing the phone consent and will receive a copy of the consent in the mail, or they will consent online and print a copy of their online consent.
Exclusion Criteria
2. The presence of other comorbid conditions known to significantly impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe COPD, uncontrolled infection or known HIV infection.)
3. Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
4. Subjects with a history of other malignancy besides current diagnosis of breast cancer who were diagnosed and treated within the last 5 years are excluded, with exception of cervical cancer definitively treated more than 2 years ago or non-melanomatous skin cancer.
18 Years
FEMALE
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Virginia Borges, MD, MMSc
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver
Aurora, Colorado, United States
Denver Health Hospital Authority
Denver, Colorado, United States
UCHealth Cherry Creek Medcial Center
Denver, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
UCHealth Lone Tree Medical Center
Lone Tree, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Hannah Parris
Role: primary
Hannah Parris
Role: primary
Hannah Parris
Role: primary
Hannah Parris
Role: primary
Hannah Parris
Role: primary
Other Identifiers
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09-0583.cc
Identifier Type: -
Identifier Source: org_study_id