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Sponsored by: |
DiaTech Oncology |
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Information provided by: | DiaTech Oncology |
ClinicalTrials.gov Identifier: | NCT00243685 |
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:
Condition | Intervention | Phase |
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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 |
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 |
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II and III: Experimental
Not applicable
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Other: Laboratory Assay
Chemotherapy
Other: Mick Assay
Chemotherapy doctor determined from results
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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.
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 |
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 |
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 |
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 |
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 |
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 |