IMAGE Study: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
IMAGE Study: Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
This study will test the feasibility of identifying patients who could benefit from tumor molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of the identification of possible actionable mutations that are not just biologically interesting but are clinically relevant. The investigators will also examine the outcome data from patients who followed the Molecular Profiling Tumor Board suggestion compared with those who did not.
When the tissue studies are done, an additional group of patients will be enrolled to test if the same is possible in blood samples.
研究概览
详细说明
The goal of this research study is to determine if it is possible to obtain personalized genetic information from a subject's tumor to see if physicians can use that information to make a treatment suggestion. The investigators hope to identify genes important to cancer cells that could potentially identify a more educated way to recommend therapy. It is not known if our suggestion for treatment based on genetic information will be the correct treatment choice.
Subjects and their treating doctor will have a choice about what treatment they will receive and do not have to decide to be treated with the suggestion from this study. In some cases it will not be possible to make a suggestion. For example, a suggestion for treatment will not be possible if there are technical issues, if the gene sequencing process takes longer than planned, or if no genes are identified that could help identify a treatment suggestion.
The investigators also plan to collect information about the treatment subjects receive and how their cancer responds to the treatment. This may help us to understand if our personalized suggestion improves the amount of time before their disease progresses.
In addition, blood samples will be collected for research studies. These samples are being collected to learn more about breast cancer by studying cells, genes, and gene products including their patterns and changes in the blood and tissue to help to learn how cancer develops and responds to therapy.
Any man or woman being seen at Johns Hopkins for treatment of metastatic triple negative (or behaving as triple negative) breast cancer may be eligible.
Upon conclusion of the tissue studies and in order to gain experience with and assess the feasibility of receiving blood-based results using blood sampling kits, we will enroll an additional cohort of patients with recent Foundation Medicine testing for clinical purposes and collect blood samples only for research testing. The primary objectives and analysis for this new cohort will proceed similarly as the original tissue-based cohort.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21287
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
MOLECULAR PROFILING IN TISSUE:
Inclusion Criteria:
- Male or Female
- 18 years of age or older
- Metastatic breast cancer and treatment with prior chemotherapy (either in adjuvant, neoadjuvant or metastatic setting)
- Triple negative clinical phenotype (ER-, PR-, HER2-). For HER2 assessment, a negative result is an immunohistochemical (IHC staining of 0 or 1+, a FISH result of less than 4.0 HER2 gene copies per nucleus, or a FISH ratio of less than 1.8. ER/PR will be assessed by IHC and will be defined as positive/negative using the American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) Guidelines. Estrogen receptor (ER) and progesterone receptor (PR) assays will be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. NOTE: A triple negative clinical phenotype based upon the patient's clinical course may also be eligible as determined at the discretion of the Study Chair (ie, if a patient is behaving clinically as ER/PR negative but does not meet the strict criteria outlined.)
- Patients must have a tumor suitable for biopsy and be deemed medically appropriate to undergo a biopsy
- Able to voluntarily provide informed consent
Exclusion Criteria:
- N/A
MOLECULAR PROFILING IN BLOOD:
Inclusion Criteria:
- Male or Female
- 18 years of age or older
- Metastatic breast cancer
- Any phenotype of breast cancer is eligible for enrollment (i.e., any ER, PR, and HER2 status).
- Able to voluntarily provide informed consent
Exclusion Criteria:
- N/A
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Molecular prolfiling in tissue
Participant's tumor will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology to provide a molecular profile for a possible treatment suggestion
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Based on any actionable findings of the molecular profiling results, the investigators will come up with a suggestion for approved treatment or for clinical trial by referencing institutional clinical trials or potentially nationwide possibilities (www.clinicaltrials.gov).
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无干预：Molecular prolfiling in blood
Participant's blood sample will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology; however, this is just being done to see if it is possible to generate similar results in blood samples.
We do not yet know if blood sample results may be used for treatment decision (this will be tested in a future study) and results will not be given to participants; therefore, no treatment suggestion will be given.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to report molecular profiling in tissue
大体时间：28 days
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To demonstrate the feasibility of real-time molecular profiling of metastatic breast cancer patients in less than 28 days from consent by evaluating the time to analysis and suggestions
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28 days
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Time to report molecular profiling in blood
大体时间：28 days
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2.1.2
To demonstrate the feasibility of real-time molecular profiling of blood samples in metastatic breast cancer patients within 4 weeks from consent to analysis
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28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ability to make treatment suggestions
大体时间：28 days
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To demonstrate the ability to make treatment suggestions based on the molecular profile of patients' tumors
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28 days
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Decisions about Molecular Profiling Tumor Board (MPTB) suggestion
大体时间：1 year
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To analyze why clinicians/patients do or do not proceed with the suggestion of the MPTB
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1 year
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Progression-free survival
大体时间：1 year
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To describe progression-free survival (PFS) for women who act on the suggestion of the MPTB and for those choosing a different therapy from our suggestion
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1 year
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Changes in plasma tumor DNA (ptDNA)
大体时间：1 year
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To prospectively follow plasma tumor DNA in all patients who take part
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1 year
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Similarities and differences of the profiling results with the different assays in tissue
大体时间：1 year
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To examine the correlation of a smaller targeted gene panel between Foundation Medicine's assay and Johns Hopkins Molecular Diagnostics Lab assay
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1 year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Similarities and differences of the profiling assay results between blood and tissue samples
大体时间：1 year
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To examine the concordance of molecular profiling in blood and tissue with Foundation Medicine's assay in patients with previously tested tumor tissue samples
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1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.