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Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis
This study is currently recruiting participants.
Verified by DiaTech Oncology, July 2009
First Received: October 20, 2005   Last Updated: July 2, 2009   History of Changes
Sponsored by: DiaTech Oncology
Information provided by: DiaTech Oncology
ClinicalTrials.gov Identifier: NCT00243685
  Purpose

DiaTech is a private company performing patient specific cancer chemosensitivity testing for patients and physicians. DiaTech Oncology is doing this clinical study to see if an experimental new technology called the microculture kinetic (MiCK) assay will predict treatment outcome and can help to direct the chemotherapy of cancer subjects. This study is focused on subjects diagnosed with breast, ovarian, lung, and colon malignancies and low-grade lymphomas.

Study Objectives:

  • To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients.
  • To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients.

Condition Intervention Phase
Breast Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Sarcoma, Soft Tissue
Other: Laboratory Assay
Other: Mick Assay
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind (Caregiver), Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Drug Testing Sensitivity of Solid Tumors

Resource links provided by NLM:


Further study details as provided by DiaTech Oncology:

Primary Outcome Measures:
  • To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients [ Time Frame: After chemotherapy ] [ Designated as safety issue: No ]
  • To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients [ Time Frame: after chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2006
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
II and III: Experimental
Not applicable
Other: Laboratory Assay
Chemotherapy
Other: Mick Assay
Chemotherapy doctor determined from results

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with pathological diagnoses of breast, lung, and ovarian adenocarcinomas and soft tissue sarcoma.
  • Patients with de novo malignancies and no previous chemotherapy
  • Patients with advanced refractory malignancies who received no more than 2 standard chemotherapy treatment protocols.
  • Patients of any age group.
  • Patients must have tumor which is accessible and agree to undergo biopsies, or drainage of effusions.
  • Patients for whom chemotherapy is a treatment option.

Exclusion Criteria:

  • Patients with symptomatic/uncontrolled parenchymal brain metastasis and non-accessible tumors.
  • Patients with meningeal metastasis.
  • Patients for whom chemotherapy is not clinically indicated.
  • 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 study medication 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 drugs, 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 childbearing 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); this also includes females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243685

Locations
United States, Tennessee
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Francie Hubbard, RN, CRC     615-284-8229 ext 118        
Principal Investigator: Pat Whitworth, MD            
Nashville Oncology Associates Recruiting
Nashville, Tennessee, United States, 37203
Contact: Karl Rogers, MD     615-284-2310     noaonc@bellsouth.net    
Contact: Connie Rogers, NP     615 284 2310     noaonc@bellsouth.net    
Principal Investigator: Karl Rogers, MD            
United States, Texas
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Glenda Chambers, RN     210-595-5683        
Principal Investigator: Alexander Zweibach, MD, PhD            
Sponsors and Collaborators
DiaTech Oncology
Investigators
Principal Investigator: Cary Presant, MD Medical Director DiaTech Oncology
Principal Investigator: Pat Whitworth, MD Director, Nashville Breast Center, PC
Principal Investigator: Alexander Zweibach, MD, PhD Cancer Care Centers of South Texas
Principal Investigator: Karl Rogers, MD Nashville Oncology Associates
  More Information

Additional Information:
No publications provided

Responsible Party: DiaTech Oncology ( Cary Presant, MD )
Study ID Numbers: 20050113
Study First Received: October 20, 2005
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00243685     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by DiaTech Oncology:
Chemosensitivity
Chemotherapy
Lung cancer
Ovarian Cancer
Breast Cancer
Sarcoma
Apoptosis
MiCK Assay
New Technology
Patients with pathological diagnoses of breast, lung, and ovarian adenocarcinomas and soft tissue sarcoma

Study placed in the following topic categories:
Thoracic Neoplasms
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Sarcoma
Ovarian Cancer
Endocrinopathy
Adenocarcinoma
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Sarcoma
Breast Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009