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

NCT00901264 | Completed

• 1 other identifier: Master Study DiaTech Oncology
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 11

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 chemotherapy of cancer patients.

Conditions

Cancer

Keywords

Chemosensitivity, chemotherapy, all cancers, personalized chemotherapy, personalized cancer treatment; Cancer Patients for whom chemotherapy is planned.

Outcome Measures

Primary Outcomes (1)

• To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients, with emphasis on patients failing primary treatment, patients with unknown primary tumors, and patients with tumors difficult to treat such as carcinoma of lung.

  one year

Secondary Outcomes (1)

• Correlate the MiCK assay results with objective response rates, symptom response rates, time to progression and survival of cancer patients treated with chemotherapy.

  one year

Study Arms (2)

1

Patients with pathological diagnoses of cancer or leukemia

2

3.1.3 Patients for whom chemotherapy is planned.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer Patients for whom chemotherapy is planned.

You may qualify if:

• Patients with pathological diagnoses of cancer or leukemia
• 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.
• Patients for whom chemotherapy is planned.

You may not qualify if:

• Patients with symptomatic/uncontrolled parenchymal brain or meningeal metastasis and tumors not accessible for biopsy.
• 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must not receive chemotherapy in this study and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study.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.

Sponsors & Collaborators

• Pierian Biosciences: lead

Study Sites (11)

Wilshire Oncology Medical Group, Inc

La Verne, California, 91750, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

DiaTech Oncology

Brentwood, Tennessee, 37027, United States

Location

Cumberland Medical Center

Crossville, Tennessee, 38555, United States

Location

Middle Tennessee Medical Center

Murfreesboro, Tennessee, 37219, United States

Location

Baptist Hospital

Nashville, Tennessee, 37203, United States

Location

Nashville Oncology Associates

Nashville, Tennessee, 37203, United States

Location

St. Thomas Research Institute, LLC

Nashville, Tennessee, 37203, United States

Location

Tennessee Breast Specialists

Nashville, Tennessee, 37203, United States

Location

Tennessee Toracic Surgical Specialists

Nashville, Tennessee, 37205, United States

Location

DiaTech Oncology

Montreal, Quebec, H2X 3P9, Canada

Location

Related Publications (1)

• Bosserman L, Rogers K, Willis C, Davidson D, Whitworth P, Karimi M, Upadhyaya G, Rutledge J, Hallquist A, Perree M, Presant CA. Application of a drug-induced apoptosis assay to identify treatment strategies in recurrent or metastatic breast cancer. PLoS One. 2015 May 29;10(5):e0122609. doi: 10.1371/journal.pone.0122609. eCollection 2015.

  PMID: 26024531 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Cary Presant, MD

  Pierian Biosciences

  STUDY DIRECTOR

• Dirk Davidson, MD

  Cumberland Medical Center

  PRINCIPAL INVESTIGATOR

• Karl Rogers, MD

  Nashville Oncology Associates

  PRINCIPAL INVESTIGATOR

• Swapnil P. Rajurkar, MD

  Wilshire Oncology Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

• Laura Lawson, MD

  Tennessee Breast Specialists

  PRINCIPAL INVESTIGATOR

• L. James Wudel Jr., MD

  Tennessee Thoracic Surgical Specialists

  PRINCIPAL INVESTIGATOR

• Raymond F Bluth, MD

  Baptist Hospital Nashville

  PRINCIPAL INVESTIGATOR

• Peter F Jelsma, MD

  St. Thomas Research Institute, LLC

  PRINCIPAL INVESTIGATOR

• Richard D Michaelson, MD

  Middle Tennessee Medical Center

  PRINCIPAL INVESTIGATOR

• Jorge E Marcet, MD

  Tampa Gerneral Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

CA (1); US (10)