Status:
COMPLETED
Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients
Lead Sponsor:
Pierian Biosciences
Conditions:
Cancer
Eligibility:
All Genders
Brief Summary
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 chemothera...
Detailed Description
Identification of those patients with cancer who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management...
Eligibility Criteria
Inclusion
- 1.1 Patients with pathological diagnoses of cancer or leukemia
- 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.
- 1.3 Patients for whom chemotherapy is planned.
Exclusion
- 2.1 Patients with symptomatic/uncontrolled parenchymal brain or meningeal metastasis and tumors not accessible for biopsy.
- 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must not receive chemotherapy in this study and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study.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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00901264
Start Date
December 1 2008
End Date
November 1 2012
Last Update
November 14 2012
Active Locations (11)
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1
Wilshire Oncology Medical Group, Inc
La Verne, California, United States, 91750
2
Tampa General Hospital
Tampa, Florida, United States, 33606
3
DiaTech Oncology
Brentwood, Tennessee, United States, 37027
4
Cumberland Medical Center
Crossville, Tennessee, United States, 38555