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Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy (ITOMIC)

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ClinicalTrials.gov Identifier: NCT01957514
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This pilot research trial studies collecting, analyzing, and storing samples from patients with triple negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein) that has spread to other places in the body receiving anti-cancer therapy. Studying samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving anti-cancer therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

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

Detailed Description:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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 Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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 Sampling
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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
Tissue, blood, buccal mucosa, saliva, urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic TNBC treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Criteria

Inclusion Criteria:

  • Subjects have metastatic TNBC and are about to receive treatment with a drug they have not received previously
  • Disease suitable for biopsy including bone disease as determined by physical exam or imaging (as assessed by a trained specialist in radiology) or have tumor tissue available from a previous biopsy as standard of care (to be determined by the principal investigator [PI] or his designee)
  • Subjects must be medically fit and willing to undergo repeated tissue biopsies or surgical procedures to get tumor tissue
  • Procedure-specific signed informed consent prior to initiation of any study-related procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (or a Karnofsky performance status of >= 50%)
  • Agree to allow their de-identified clinical and laboratory data to be posted to publicly available databases such as database of Genotypes and Phenotypes (dbGaP)

Exclusion Criteria:

  • Bevacizumab treatment within 4 weeks prior to biopsy
  • Anticoagulation therapy, unless reversed at the time of biopsy
  • The enrolling study oncologist has decided that the subject is not fit enough to undergo repeated tissue biopsies
  • Presence of a condition or abnormality that in the opinion of the enrolling investigator would compromise the safety of the subject or the quality of the data
  • Significant bleeding disorder
  • Known brain metastases that have not or will not be treated
  • Subjects with a life expectancy of less than 6 months
  • Prisoners
  • Inability to give informed consent
Contacts and Locations

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): NCT01957514


Locations
United States, Arkansas
Highlands Oncology Group PA - Fayetteville Not yet recruiting
Fayetteville, Arkansas, United States, 72703
Contact: J. Thaddeus Beck    479-872-8130    tbeck@hogonc.com   
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    tblau@u.washington.edu   
Principal Investigator: Anthony Blau         
Northwest Medical Specialties PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: Sibel Blau    253-428-8700    sblau2@nwmsonline.com   
Principal Investigator: Sibel Blau         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anthony Blau Fred Hutch/University of Washington Cancer Consortium
More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01957514     History of Changes
Other Study ID Numbers: 8132
NCI-2013-01654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ITOMIC-001
UW13022
8132 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases