NCT02137811

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

April 23, 2014

Last Update Submit

July 20, 2016

Conditions

Cancer

Keywords

cancerCorrectChemoassaylab testMICK assayapoptosisincrease survivalincrease response ratesdecrease time to progressionchemotherapycancer treatment

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan

    6 months

  • How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan

    12 months

  • How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan

    24 months

Other Outcomes (3)

  • Physician attitudes

    6 months

  • Physician attitudes

    12 months

  • Physician attitudes

    24 months

Study Arms (1)

Patients that received MICK assay

Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) test performed

Other: MICK Assay

Interventions

MICK AssayOTHER

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.

Also known as: CorrectChemo
Patients that received MICK assay

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) performed

You may qualify if:

  • Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (Correct Chemo) performed

You may not qualify if:

  • Patients whose physician refuses to provide data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DiaTech Oncology

Franklin, Tennessee, 37069, United States

Location

DiaTech Oncology

Montreal, Quebec, H2X3P9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Allan Hallquist, MD

    Pierian Biosciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 14, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

US(1)CA(1)