Clinical trial NCT02137811: Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)
Official title: Chart Review of Demographics and Clinical Outcomes and Physician Attitudes in Patients Who Have Received the Microculture Kinetic (MiCK) Apoptosis Test
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Keywords: cancer
CorrectChemo
assay
lab test
MICK assay
apoptosis
increase survival
increase response rates
decrease time to progression
chemotherapy
cancer treatment
Lead sponsor: Pierian Biosciences
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) performed

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical composite outcomes
timeFrame: 6 months
measure: Clinical composite outcomes
timeFrame: 12 months
measure: Clinical composite outcomes
timeFrame: 24 months
Secondary outcomes:
measure: How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
timeFrame: 6 months
measure: How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
timeFrame: 12 months
measure: How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
timeFrame: 24 months
Other outcomes:
measure: Physician attitudes
timeFrame: 6 months
measure: Physician attitudes
timeFrame: 12 months
measure: Physician attitudes
timeFrame: 24 months
Locations:
city: Franklin
country: United States
facility: DiaTech Oncology
state: Tennessee
city: Montreal
country: Canada
facility: DiaTech Oncology
state: Quebec
Study officials:
affiliation: Pierian Biosciences
name: Allan Hallquist, MD
role: PRINCIPAL_INVESTIGATOR
References: