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Trial record 1 of 1 for:    NCT03737695
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Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT03737695
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : February 27, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
This trial collects clinical information and tissue and blood samples from patients with breast cancer that has come back or is stage IV. Collecting clinical information and biospecimen samples to create a registry may help doctors better understand the mechanism of tumor spread and determine why people respond differently to specific cancer treatments.

Condition or disease Intervention/treatment
Anatomic Stage IV Breast Cancer AJCC v8 Ascites Invasive Breast Carcinoma Metastatic Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Breast Carcinoma Procedure: Biospecimen Collection Other: Medical Chart Review

Detailed Description:

PRIMARY OBJECTIVES:

I. To create a comprehensive registry that includes patient demographics, clinical and histopathological data, blood samples, and tissue specimens from the primary tumor and metastatic sites of patients with metastatic breast cancer to improve our understanding of the mechanisms of tumor metastasis and therapeutic resistance.

II. To conduct genomic studies of paired primary tumors and distant metastatic sites.

III. To conduct genomic studies of paired distant metastatic sites obtained during the course of an individual's disease.

IV. To conduct genomic studies of cell free deoxyribonucleic acid (DNA), circulating tumor cell (CTC) derived DNA, germline DNA, and immune based markers in the peripheral circulation.

SECONDARY OBJECTIVE:

I. To evaluate the concordance between DNA sequencing results obtained from a clinically available assay and those obtained specifically for research purposes.

OUTLINE:

Patients' archival and newly collected tissue and blood samples are collected periodically for genetic testing. Patients also undergo collection of clinical information within 30 days of biopsy procedure and every 4 months.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 15, 2023
Estimated Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (biospecimen, clinical info collection)
Patients' archival and newly collected tissue and blood samples are collected periodically for genetic testing. Patients also undergo collection of clinical information within 30 days of biopsy procedure and every 4 months.
 Procedure: Biospecimen Collection
Undergo biospecimen collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Other: Medical Chart Review
Undergo clinical information collection
Other Name: Chart Review


Outcome Measures
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Primary Outcome Measures :
  1. Comprehensive biorepository creation [ Time Frame: Up to 2 years ]
    Will create a comprehensive biorepository that includes blood, archival tissue, fresh tissue, and linked molecular and clinical data from patients with recurrent and/or metastatic breast cancer.


Biospecimen Retention:   Samples With DNA
Tissue, blood

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recurrent and/or metastatic breast cancer of all tumor subtypes
Criteria

Inclusion Criteria:

  • Histologically confirmed or suspected invasive breast cancer
  • Radiographic evidence of distant metastatic disease
  • Clinical or radiographic evidence of disease progression OR presenting with de novo stage IV disease
  • Available archived tissue from the initial breast primary (formalin fixed paraffin embedded [FFPE] tissue is acceptable; fresh frozen tissue is preferred if available)

  • Accessible lesion representative of recurrent or metastatic breast cancer for biopsy

    • Type 1 specimen collection: Patients undergoing a clinically directed tissue biopsy or tissue collection who are willing to have additional specimens taken for research during the same procedure. Sites for tissue acquisition may include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, lung, brain, pleural fluid, and ascites as needed for routine clinical care
    • Type 2 specimen collection: Patients undergoing a tissue biopsy or tissue collection for research purposes only. Sites for tissue acquisition include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, pleural fluid, and ascites. Research directed lung biopsies and brain biopsies are not permitted. Procedures for tissue acquisition are restricted to those performed under local anesthesia or intravenous (IV) conscious sedation; biopsies that require general anesthesia are not permitted in this situation
  • Previous cytologic confirmation of malignant pleural effusion or ascites if that is the planned source of fresh specimen collection for study participation
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

  • Concurrent disease or condition that in the opinion of the treating oncologist or the provider performing the biopsy procedure renders the patient inappropriate for study participation
  • Concurrent serious medical or psychiatric disorder that may interfere with the subject's safety during the biopsy or tissue collection procedure
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
  • History of a serious or life-threatening allergic reaction to local anesthetics (e.g., lidocaine, xylocaine) used during a biopsy procedure
  • Pregnancy (due to the risk of conscious sedation or anesthesia to mother and fetus)
  • Any condition or laboratory finding that in the opinion of the treating oncologist or the provider performing the biopsy procedure would make participation in this protocol hazardous for the patient
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03737695


Locations
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United States, California
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Amy N. DeLuca    415-353-7288    amy.deluca@ucsf.edu   
Principal Investigator: Amy N. DeLuca         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Claudine Isaacs    202-687-2219    isaacsc@georgetown.edu   
Principal Investigator: Claudine Isaacs         
United States, Illinois
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Rita Nanda       rnanda@medicine.bsd.uchicago.edu   
Principal Investigator: Rita Nanda         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jessica Jelinek    410-614-1361    HopkinsBreastTrials@jhmi.edu   
Principal Investigator: Jessica Tao         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy U. Lin       nlin@partners.or   
Principal Investigator: Nancy U. Lin         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nancy McCullough    734-936-8538    ntsai@med.umich.edu   
Principal Investigator: Catherine H. Van Poznak         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Minetta C. Liu, M.D.         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kendalyn Stephens    919-962-5052    kendalyn_stephens@med.unc.edu   
Principal Investigator: Lisa A. Carey         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Keiana K. Watkins    919-660-1278    breastoncreg@dm.duke.edu   
Principal Investigator: Keiana K. Watkins         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Noah Goodman-Davis       Noah.Goodman@pennmedicine.upenn.edu   
Principal Investigator: Angela M. DeMichele         
UPMC-Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Trisha N. Schneider    412-641-4706      
Principal Investigator: Adam M. Brufsky         
United States, Tennessee
Vanderbilt Breast Center at One Hundred Oaks Recruiting
Nashville, Tennessee, United States, 37204
Contact: Ben H. Park    800-811-8480    ben.h.park@vumc.org   
Principal Investigator: Ben H. Park         
United States, Washington
FHCC South Lake Union Recruiting
Seattle, Washington, United States, 98109
Contact: Shaveta Vinayak       broncresearch@seattlecca.org   
Principal Investigator: Shaveta Vinayak         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Minetta C Liu Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03737695    
Other Study ID Numbers: AURORA US
NCI-2018-02144 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AURORA
18-001910
AURORA US ( Other Identifier: Mayo Clinic in Rochester )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Ascites
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Pathologic Processes