Estrogen Receptor NegativeITOMICNCT01957514
Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy
An observational study of Estrogen Receptor Negative and HER2/Neu Negative, run by University of Washington at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative
- What is being tested?
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Quality-of-Life Assessment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2013to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic TNBC treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Who may be able to join
- Subjects have metastatic TNBC
- Disease suitable for analysis from either (a) or (b) below:
- (a) Research biopsy
- Tumor tissue, which can include bone disease, as determined by physical exam or imaging (as assessed by a trained specialist in radiology)
- Must be collected before the subject receives treatment with a drug they have not received previously
- (b) Standard of care biopsy
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- Tumor tissue available from a previous biopsy as standard of care (to be determined by the principal investigator [PI] or his designee)
- Must have been collected before subject receives treatment with a drug they have not received previously
- May begin treatment either after enrollment or within several weeks prior to enrollment
- 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)
Who cannot join
- 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
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- Subjects with a life expectancy of less than 6 months
- Prisoners
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
About this study
Official title: Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Stage IV Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (sample collection) | Patients undergo collection of tissue biopsy, blood, buccal swab, saliva, and urine at baseline. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The frequency of adverse events associated with multiple repeated study-related biopsies (or leukapheresis runs) will be determined using simple statistics.
Measured: Within 1 week of biopsy
Infrastructure for acquiring, storing, retrieving and analyzing panomic data from clinical tumor specimens in a clinically relevant timeframe from participating sites
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.
Measured: Up to 2 years
Secondary outcomes (7)
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
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.
Measured: Baseline to 2 years
Develop process improvements
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.
Measured: Up to 2 years
Development and improvement of infrastructure for storing and working with data from subject biopsies
Data from subjects will be used to test the infrastructure being developing and identify areas that need to be improved.
Measured: Up to 2 years
Methods required to analyze and integrate data across subjects and with data from the public domain
Methods and software that can facilitate comparing data from subjects with that deposited in the public domain will be developed.
Measured: Up to 2 years
Molecular changes associated with treatment response or resistance
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.
Measured: Up to 2 years
Number or frequencies of biopsies or leukapheresis runs
Safety and feasibility data will be analyzed and the frequency, nature, and severity of adverse events will be summarized.
Measured: Up to 2 years
Removal of any unnecessary biopsies or generation of redundant data
Data across biopsies taken from the same individual at the same time point will be compared to assess the need for multiple biopsies.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start28 Oct 2013
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: Terminated due to loss of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor NegativeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijun Duan, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957514
- Sponsor's protocol ID
- 8132
- Other IDs
- NCI-2013-01654, ITOMIC-001, UW13022, 8132, RG1013004
- Acronym
- ITOMIC
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2013
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01957514
- Acronym / sponsor ID
- ITOMIC / 8132
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Stage IV Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to loss of funding.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (sample collection) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo collection of tissue biopsy, blood, buccal swab, saliva, and urine at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic TNBC treated at Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Key inclusion criteria (13 listed)
- Subjects have metastatic TNBC
- Disease suitable for analysis from either (a) or (b) below:
- 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%)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection | Other | Ancillary-Correlative (sample collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (sample collection) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Ancillary-Correlative (sample collection) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-Correlative (sample collection) |
Primary outcome
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.
7 secondary outcomes
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
Develop process improvements
Time frame: Up to 2 years
Development and improvement of infrastructure for storing and working with data from subject biopsies
Time frame: Up to 2 years
Methods required to analyze and integrate data across subjects and with data from the public domain
Time frame: Up to 2 years
Molecular changes associated with treatment response or resistance
Time frame: Up to 2 years
Number or frequencies of biopsies or leukapheresis runs
Time frame: Up to 2 years
Removal of any unnecessary biopsies or generation of redundant data
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Terminated due to loss of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhijun Duan principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Estrogen Receptor Negative and HER2/Neu Negative, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to loss of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.