Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients

Completed

Conditions studied: Cancer

In brief

The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.

Key facts

Study ID

NCT00901264

Run by

Pierian Biosciences

People needed

300

Starts

2008-12-01

Expected to finish

2012-11-01

Last updated by the study team

2012-11-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 3.1.1 Patients with pathological diagnoses of cancer or leukemia
• 3.1.2 Patients must have tumor which is accessible for biopsy and agree to undergo tumor biopsy, or drainage of malignant effusion, and the specimen must be submitted for MiCK assay.
• 3.1.3 Patients for whom chemotherapy is planned.

You may not qualify if…

• 3.2.1 Patients with symptomatic/uncontrolled parenchymal brain or meningeal metastasis and tumors not accessible for biopsy.
• 3.2.2 Patients who are pregnant. Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive chemotherapy in this study and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of child bearing potential are defined to include any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); these includes also females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.

Where it is running

• Wilshire Oncology Medical Group, Inc — La Verne, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• DiaTech Oncology — Brentwood, Tennessee, United States
• Cumberland Medical Center — Crossville, Tennessee, United States
• Middle Tennessee Medical Center — Murfreesboro, Tennessee, United States
• Baptist Hospital — Nashville, Tennessee, United States
• Nashville Oncology Associates — Nashville, Tennessee, United States
• St. Thomas Research Institute, LLC — Nashville, Tennessee, United States
• Tennessee Breast Specialists — Nashville, Tennessee, United States
• Tennessee Toracic Surgical Specialists — Nashville, Tennessee, United States
• DiaTech Oncology — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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