Precision Medicine for Patients With Malignancy at the Comprehensive Cancer Center of Wake Forest University
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams.
研究概览
简要总结
This pilot clinical trial studies patients' genomic sequencing in determining specific treatments, also called Precision Medicine, in patients with cancer that has spread to other parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid [DNA] sequence of a cell or gene) may be identified and matched with available treatment that targets the mutated gene or an alternative treatment that may provide benefit for the patient with the mutation identified. Precision medicine may impacts patient's response to treatment by targeting specific mutations and may increase survival and improve quality of life.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility of implementing a Precision Oncology protocol in the treatment of patients who undergo genomic sequencing.
SECONDARY OBJECTIVES:
I. To determine treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment.
II. To assess survival in patients who receive targeted treatment versus those who do not receive targeted treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable cancer for which there are genomic drivers with corresponding Food and Drug Administration (FDA) approved or experimental drugs available, e.g. non-small cell lung cancer; and/or patients with histologically confirmed metastatic malignancy that have failed standard treatment or cannot tolerate standard treatment as deemed by the treating physician
- •Malignancy must be measureable as per appropriate guidelines
- •Patients who are willing to provide a specimen for genomic sequencing
- •Preferred method:
- •Tumor cell sample available and of sufficient quantity in the Tumor Tissue Shared Resource or patients who are willing to undergo additional tissue collection for tumor genomic sequencing through FoundationOne; available specimens must have been harvested within two years to be eligible
- •Alternative method:
- •Patients who are unwilling or unable to provide a tumor tissue sample and who undergoes Guardant360 sequencing may be considered eligible by the treating physician
- •Patients who have already had their specimens sent for genomic sequencing are eligible provided they have not received their sequencing results at the time of enrollment
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Absence of clinically relevant liver or kidney failure as deemed by the treating physician
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
排除标准
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diminished mental capacity or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnancy or lactation
研究组 & 干预措施
Treatment (precision medicine)
Patients receive treatment based on the results of their genomic sequencing analyses.
干预措施: Quality-of-Life Assessment (Other)
Treatment (precision medicine)
Patients receive treatment based on the results of their genomic sequencing analyses.
干预措施: Targeted Therapy (Other)
Treatment (precision medicine)
Patients receive treatment based on the results of their genomic sequencing analyses.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams.
时间窗: Up to 2 years
Typical patient outcome measures will necessarily vary by disease, so survival will be the overarching outcome measure.
Proportion of patients enrolled on this protocol who are subsequently enrolled in a clinical trial based on the results of the genomic sequencing
时间窗: Baseline
Proportion of patients with an actionable mutation
时间窗: Baseline
Each patient enrolled will be dichotomized into either having a clinical trial identified (yes/no) that the results of their genomic sequencing suggests. The observed proportion and corresponding 95% confidence intervals will be estimated.
Feasibility in terms of the ability to monitoring patient adverse events across separate treatment protocols and study teams.
时间窗: Up to 2 years
Proportion of patients enrolled on this protocol who have a clinical trial identified for them to be enrolled in based on the results of the genomic sequencing
时间窗: Baseline
The observed proportion and corresponding 95% confidence intervals will be estimated.
次要结局
- Patient's perceived quality care, as assessed by 3 items adapted from Arora, et al(Up to up to 48 weeks)
- Change in patient-reported symptoms of cancer and cancer treatment, as assessed by the MD Anderson Symptom Inventory(Baseline to up to 48 weeks)
- Patient's satisfaction with treatment decision-making and decisional regret, as assessed by an adapted Satisfaction with Decision scale(Up to up to 48 weeks)
- Self-perceived burden, as assessed by the Self-Perceived Burden Scale-Short form for measuring chronic disease patients' feelings of being a burden on their caregivers(Up to up to 48 weeks)
- Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment(Up to 12 months)
- Treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment(Up to 2 years)