Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Cisplatin (ITOMIC)
This pilot research trial studies collecting, analyzing, and storing samples from patients with metastatic, triple negative breast cancer receiving cisplatin. Studying samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving cisplatin may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
Estrogen Receptor Negative
Progesterone Receptor Negative
Stage IV Breast Cancer
Triple-Negative Breast Carcinoma
Other: Laboratory Biomarker Analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Patients With Triple-Negative Breast Cancer|
- Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Safety of performing multiple biopsies over time measured by the presence of biopsy-related complications, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)4.0 [ Time Frame: Within 1 week of biopsy ] [ Designated as safety issue: Yes ]
- Change in patient perceptions regarding panomic data and its application to cancer treatment [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]
- Develop process improvements by monitoring the yield of successfully performing various types of analyses from biopsy specimens as well as the time frame necessary for returning reports to patients and their oncologists [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Development and improvement of infrastructure for storing and working with data from patient biopsies [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Methods required to analyze and integrate data across patients and with data from the public domain [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Molecular changes associated with treatment response or resistance [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Number or frequencies of biopsies or leukapheresis runs [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
- Removal of any unnecessary biopsies or generation of redundant data [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tissue, blood, buccal mucosa, saliva, urine
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Ancillary-Correlative (sample collection)
Patients undergo collection of tissue biopsy, blood, buccal swab, saliva, and urine at baseline.
Other: Laboratory Biomarker Analysis
I. To establish the safety and feasibility of collecting, analyzing and storing panomic and other data from serially monitored patients with cancer in a manner that is scientifically useful.
I. To determine whether genetic changes associated with cisplatin resistance can be identified, to explore patient perceptions regarding panomic data and its application to cancer treatment, and to apply other technologies to the characterization of patient tumors as they become available.
Patients undergo collection of tissue biopsy, blood, buccal mucosa, saliva, and urine at baseline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957514
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Anthony Blau 206-685-6873 firstname.lastname@example.org|
|Principal Investigator: Anthony Blau|
|Northwest Medical Specialties PLLC||Recruiting|
|Tacoma, Washington, United States, 98405|
|Contact: Sibel Blau 253-841-4296 email@example.com|
|Principal Investigator: Sibel Blau|
|Principal Investigator:||Anthony Blau||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|