Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)
Chart Review of Demographics and Clinical Outcomes and Physician Attitudes in Patients Who Have Received the Microculture Kinetic (MiCK) Apoptosis Test
Recently an automated test for measuring cancer cell death in the presence of chemotherapy has been developed. This test has been called the MiCK assay during the ten year development phase and is now called Correct Chemo.
CorrectChemo provides the medical community and patients a way to determine the effects of different chemotherapies on individual cancer cells.
MiCK assay has been proven to have clinical usefulness in two studies. In one study using multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the physician used the results to prescribe the chemotherapy treatment, the patients' response rate, time to the disease getting worse, and overall survival were all significantly better compared to patients whose physicians did not use the results. In another study of breast cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used when planning chemotherapy, response rate and time to the disease started getting worse were all significantly better compared to patients whose physicians did not use the results of the MiCK assay The purpose of this study is to compare the outcomes of patients who have had the MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and how the physicians used the test. This study will be gathering this data by reviewing medical charts.
研究概览
详细说明
The purpose of this study is to correlate the clinical outcomes of patients who have had the MICK assay with tumor type, physician attitudes towards the assay, and how physicians used the assay by using data in patient charts, and surveying physician attitudes.
Study Objectives:
- To determine how often physicians use the MiCK assay results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
- To determine physician attitudes towards the MiCK assay.
- To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay. This will be correlated with pattern of physician use of the assay.
Treatment Plan:
- The treating oncologist will provide demographic information (patient identifying number, sex, age, number of prior lines of therapy, performance status) and tumor information (cell type, stage, metastatic sites, goal of therapy, pre-assay planned therapy, and post-assay therapy chosen for
- Tumor response, patient symptom response, time to progression on each chemotherapy regimen, and overall survival will be determined from the patient chart and will be correlated with MICK assay results.
- Physicians will complete a questionnaire on attitudes towards usefulness of the assay.
Statistics
- Investigators will correlate tumor response, symptom response, time to progression and overall survival with drug therapy with drug response in MICK assay for first chemo regimen after assay, and according to pattern of physician use of the assay.
- We will accumulate physician attitudes toward usefulness of the assay.
Informed Consent Since this study has no risk to the patient, informed consent will not be needed. Physicians will have the option of participating, or not participating, in each patient. Physicians will be compensated for completing chart review and submitting data after the MiCK assay has been performed, and at 6,12 and 24 months after MiCK assay.
Data Collection from Physicians Data will include demographics and tumor characteristics and physician attitudes: I used the test to develop a treatment plan yes/no, I found the test useful yes/no, I found the test to be helpful in planning for palliative care yes/no, I found the test to be helpful in planning for hospice yes/no. I have these suggestions for improvement (free text response). Data will include at 6,12 and 24 months clinical outcomes as judged by the physician: Complete, Partial, Stable, Death, symptomatic improvement patient felt better same or worse. Data will include at time of progression, did doctor use the MiCK assay to plan the next treatment, try to get another MiCK assay, or use the assay to plan for palliative care or hospice.
研究类型
联系人和位置
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (Correct Chemo) performed
Exclusion Criteria:
- Patients whose physician refuses to provide data.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Patients that received MICK assay
Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) test performed
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An automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells; the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells.
其他名称:
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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 |
---|---|---|
Clinical composite outcomes
大体时间:6 months
|
To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo.)
This will be correlated with pattern of physician use of the assay.
|
6 months
|
Clinical composite outcomes
大体时间:12 months
|
To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo).
This will be correlated with pattern of physician use of the assay.
|
12 months
|
Clinical composite outcomes
大体时间:24 months
|
To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo.)
This will be correlated with pattern of physician use of the assay.
|
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
大体时间:6 months
|
To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment.
This will be correlated with patient and tumor demographics.
|
6 months
|
How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
大体时间:12 months
|
To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment.
This will be correlated with patient and tumor demographics.
|
12 months
|
How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
大体时间:24 months
|
To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment.
This will be correlated with patient and tumor demographics.
|
24 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Physician attitudes
大体时间:6 months
|
To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment.
This will be correlated with patient and tumor demographics.
|
6 months
|
Physician attitudes
大体时间:12 months
|
To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment.
This will be correlated with patient and tumor demographics.
|
12 months
|
Physician attitudes
大体时间:24 months
|
To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment.
This will be correlated with patient and tumor demographics.
|
24 months
|
合作者和调查者
调查人员
- 首席研究员:Allan Hallquist, MD、Pierian Biosciences
研究记录日期
研究主要日期
学习开始
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 1143088
- 187128 (其他赠款/资助编号:DiaTech)
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MICK Assay的临床试验
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Foundation for Innovative New Diagnostics, SwitzerlandUNITAID完全的
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Memorial Sloan Kettering Cancer CenterXcovery Holding Company, LLC主动,不招人