Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)

Cancer Clinical Trial

Official title:

Chart Review of Demographics and Clinical Outcomes and Physician Attitudes in Patients Who Have Received the Microculture Kinetic (MiCK) Apoptosis Test

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02137811
• Other study ID #: 1143088
• Secondary ID: 187128
• Status: Withdrawn
• Phase: N/A
• First received: April 23, 2014
• Last updated: July 20, 2016
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: DiaTech Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. 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.

2. To determine physician attitudes towards the MiCK assay.

3. 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:

1. 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

2. 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.

3. Physicians will complete a questionnaire on attitudes towards usefulness of the assay.

Statistics

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• MICK Assay
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.

Locations

Country	Name	City	State
Canada	DiaTech Oncology	Montreal	Quebec
United States	DiaTech Oncology	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
DiaTech Oncology

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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.	12 months	No
Other	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No