Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy (ITOMIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01957514|
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment|
|Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Stage IV Breast Cancer AJCC v6 and v7 Triple-Negative Breast Carcinoma||Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration|
I. To establish the safety and feasibility of collecting, analyzing and storing clinically annotated panomic and other data from serially monitored subjects with metastatic triple negative breast cancer (TNBC) who receive care from up to ten oncology practices across the United States.
I. To determine whether molecular changes associated with resistance to treatment can be identified.
II. To understand subject perceptions regarding panomic data and its application to cancer treatment.
III. To apply other technologies to the characterization of subject tumors as they become available.
Patients undergo collection of tissue biopsy, blood, buccal mucosa, saliva, and urine at baseline. Additional biopsies may be performed prior to treatment change.
After completion of biopsy, patients are followed up at 1 day and 7 days. Patients will be followed indefinitely or for as long as they agree to be in the study, depending on the availability of resources.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer|
|Actual Study Start Date :||October 28, 2013|
|Estimated Primary Completion Date :||November 1, 2018|
Ancillary-Correlative (sample collection)
Patients undergo collection of tissue biopsy, blood, buccal swab, saliva, and urine at baseline.
Other: Cytology Specimen Collection Procedure
Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection
Other Name: Cytologic SamplingOther: Laboratory Biomarker Analysis
Correlative studiesOther: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentOther: Questionnaire Administration
- Incidence of adverse events resulting from performing multiple biopsies measured by the presence of biopsy-related complications, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Within 1 week of biopsy ]The frequency of adverse events associated with multiple repeated study-related biopsies (or leukapheresis runs) will be determined using simple statistics.
- Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe from participating sites [ Time Frame: Up to 2 years ]Findings of potential clinical significance will be included in the reports provided to subjects and oncologists. Similarly, as new information becomes available, information of significance to understanding a subject's tumor or germline genomes may become apparent.
- Change in subject perceptions regarding panomic data and its application to cancer treatment assessed by Intensive Trial of OMics in Cancer baseline and follow up questionnaires [ Time Frame: Baseline to 2 years ]Subject perceptions regarding the value of panomic testing in predicting the optimal treatment for subjects with cancer and for predicting the risk for developing other inherited diseases will be collected.
- Develop process improvements [ Time Frame: Up to 2 years ]The yield of successfully performing various types of analyses from clinically indicated- and study-related biopsies and leukapheresis specimens as well as the time frame necessary for returning reports will be monitored.
- Development and improvement of infrastructure for storing and working with data from subject biopsies [ Time Frame: Up to 2 years ]Data from subjects will be used to test the infrastructure being developing and identify areas that need to be improved.
- Methods required to analyze and integrate data across subjects and with data from the public domain [ Time Frame: Up to 2 years ]Methods and software that can facilitate comparing data from subjects with that deposited in the public domain will be developed.
- Molecular changes associated with treatment response or resistance [ Time Frame: Up to 2 years ]A number of statistical approaches will be used. Will be evaluated by comparing biopsies taken from the same subject pre- and post- anti-cancer treatment, and relating these changes to each subject's outcome.
- Number or frequencies of biopsies or leukapheresis runs [ Time Frame: Up to 2 years ]Safety and feasibility data will be analyzed and the frequency, nature, and severity of adverse events will be summarized.
- Removal of any unnecessary biopsies or generation of redundant data [ Time Frame: Up to 2 years ]Data across biopsies taken from the same individual at the same time point will be compared to assess the need for multiple biopsies.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957514
|United States, Arkansas|
|Highlands Oncology Group PA - Fayetteville||Not yet recruiting|
|Fayetteville, Arkansas, United States, 72703|
|Contact: J. Thaddeus Beck 479-872-8130 firstname.lastname@example.org|
|Principal Investigator: J. Thaddeus Beck|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Anthony Blau 206-685-6873 email@example.com|
|Principal Investigator: Anthony Blau|
|Northwest Medical Specialties PLLC||Recruiting|
|Tacoma, Washington, United States, 98405|
|Contact: Sibel Blau 253-428-8700 firstname.lastname@example.org|
|Principal Investigator: Sibel Blau|
|Principal Investigator:||Anthony Blau||Fred Hutch/University of Washington Cancer Consortium|