Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial, An Umbrella Protocol
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Purpose
Primary Objective The primary objective of this study is to establish a program for the molecular profiling of patients with advanced cancer, with the goals of (1) providing a comprehensive characterization of the molecular profiles of individual patients and (2) correlating molecular profile with response to phase I therapies.
Specimens will be received from the LAB07-0817 (Tissue Bank) protocol in the Department of Investigational Cancer Therapeutics. Note that this study is considered an umbrella protocol to systematically enroll phase I patients for molecular profiling analysis and correlate the results with treatment outcomes. The IMPACT trial is not a treatment protocol.
Secondary Objectives
- To characterize advanced cancer by delineating genetic mutations, amplifications, translocations, and other defining molecular patient characteristics.
- To assess the antitumor effects of treatments by tumor responses using the World Health Organization (WHO) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria and/or any other clinical benefits, including progression-free survival and overall survival, demonstrated in phase I clinical trials.
- To correlate molecular profiles of patients with evidence of antitumor activity (complete remission, partial remission, prolonged stable disease, or overall survival) to define subsets of patients who will respond to specific therapies in clinical trials of novel agents.
- To correlate molecular profiles with toxicities induced by investigational agents to define subsets of patients who may or may not be candidates for treatment with these agents in the future.
| Condition | Intervention |
|---|---|
|
Advanced Cancers |
Other: Molecular Profiling Analyses |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | An Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial. A Molecular Profile-Based Study in Patients With Advanced Cancer Treated in the Investigational Cancer Therapeutics Program |
- Establish a program for the molecular profiling of patients with advanced cancer. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Specimen obtained from MDACC Tissue Bank.
| Estimated Enrollment: | 2500 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Molecular Profiling Analyses |
Other: Molecular Profiling Analyses
Molecular profiling analyses from advanced cancer patients' stored tissue bank samples.
|
Detailed Description:
The prognosis of patients with advanced metastatic malignancies is poor, and their median survival, irrespective of diagnosis, is approximately 8.8 months (95% confidence interval, 7.4 to 10.9 months). In recent years there has been increased interest in novel agents.
Elucidating the molecular basis of advanced cancer will lead to the development of potentially curative strategies for these diseases aimed at the specific molecular and genetic aberrations characteristic of specific tumors.
This study is a molecular profiling analyses of the patients' stored samples and will not involve more than minimal risk to the subjects. Subjects are at no more than minimal risk because only leftover blood, tissue, and patient data will be used for this study, and all patient data will be kept confidential.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Advanced Cancer Treated in the Investigational Cancer Therapeutics Program Registered on MDACC tissue bank protocol (LAB07-0817).
Inclusion Criteria:
1) Any patient seen in the department of Investigational Cancer Therapeutics is eligible. Patients who have blood or tissue samples collected must be registered on the tissue bank protocol (LAB07-0817).
Exclusion:
N/A
Contacts and Locations| Contact: Apostolia M. Tsimberidou, MD, PhD | 713-792-4259 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Apostolia Tsimberidou, MD, PhD | |
| Study Chair: | Apostolia M. Tsimberidou, MD, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00851032 History of Changes |
| Other Study ID Numbers: | 2007-0885 |
| Study First Received: | February 23, 2009 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Initiative for Molecular Profiling in Advanced Cancer Therapy IMPACT Molecular Profile-Based Study |
Investigational Cancer Therapeutics Program Molecular profiling Phase I Therapies Tissue Bank |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013