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| Sponsor: | 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:
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: II and III
Not applicable
|
Other: Laboratory Assay
Chemotherapy
Other Name: Comparison of differnt drugs
Other: Mick Assay
Chemotherapy doctor determined from results
Other Name: Chemotherapy
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Nashville Breast Center | |
| Nashville, Tennessee, United States, 37203 | |
| Nashville Oncology Associates | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Cancer Care Centers of South Texas | |
| San Antonio, Texas, United States, 78229 | |
| 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
| Responsible Party: | Cary Presant, MD, DiaTech Oncology |
| ClinicalTrials.gov Identifier: | NCT00243685 History of Changes |
| Other Study ID Numbers: | 20050113 |
| Study First Received: | October 20, 2005 |
| Last Updated: | January 25, 2012 |
| 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 |
|
Breast Neoplasms Neoplasms Lung Neoplasms Ovarian Neoplasms Sarcoma Neoplasms by Site Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |