Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- •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
结局指标
主要结局
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
时间窗: 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
时间窗: 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.
次要结局
- Develop process improvements(Up to 2 years)
- Methods required to analyze and integrate data across subjects and with data from the public domain(Up to 2 years)
- Removal of any unnecessary biopsies or generation of redundant data(Up to 2 years)
- Molecular changes associated with treatment response or resistance(Up to 2 years)
- Number or frequencies of biopsies or leukapheresis runs(Up to 2 years)
- 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(Baseline to 2 years)
- Development and improvement of infrastructure for storing and working with data from subject biopsies(Up to 2 years)