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| ID | Type | Description | Link |
|---|---|---|---|
| 187128 | Other Grant/Funding Number | DiaTech |
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Company decided to remove CLIA test from Market.
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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.
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:
Treatment Plan:
Statistics
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients that received MICK assay | Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) test performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICK Assay | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical composite outcomes | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician attitudes | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) performed
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| Name | Affiliation | Role |
|---|---|---|
| Allan Hallquist, MD | Pierian Biosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DiaTech Oncology | Franklin | Tennessee | 37069 | United States | ||
| DiaTech Oncology |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan |
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 | 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 |
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 | 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 |
| Montreal |
| Quebec |
| H2X3P9 |
| Canada |