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Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial, An Umbrella Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851032
Recruitment Status : Unknown
Verified May 2019 by M.D. Anderson Cancer Center.
Recruitment status was:  Recruiting
First Posted : February 25, 2009
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

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

  1. To characterize advanced cancer by delineating genetic mutations, amplifications, translocations, and other defining molecular patient characteristics.
  2. 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.
  3. 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.
  4. 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 or disease Intervention/treatment
Advanced Cancers Other: Molecular Profiling Analyses

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
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
Actual Study Start Date : February 2009
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Molecular Profiling Analyses
Participants seen in the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center in Houston, Texas
 Other: Molecular Profiling Analyses
Molecular profiling analyses from advanced cancer participants' stored tissue bank samples.


Outcome Measures
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Primary Outcome Measures :
  1. Establish a program for the molecular profiling of patients with advanced cancer. [ Time Frame: 6 Years ]
    For characterizing the molecular profile, descriptive statistics and exploratory data analysis performed first. Categorical data described using contingency tables. Continuously scaled measures summarized with descriptive statistical measures (i.e., mean (± s.d.) and median (range)). Distribution plots such as histograms and box plots applied.


Biospecimen Retention:   Samples With DNA
Specimen obtained from MDACC Tissue Bank.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Advanced Cancer Treated in the Investigational Cancer Therapeutics Program Registered on MDACC tissue bank protocol (LAB07-0817).
Criteria

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 Criteria:

N/A

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851032


Contacts
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Contact: Apostolia M. Tsimberidou, MD, PhD 713-792-4259 atsimber@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Apostolia Tsimberidou, MD, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Center for Research Resources (NCRR)
Investigators
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Study Chair: Apostolia M. Tsimberidou, MD, PHD M.D. Anderson Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00851032    
Other Study ID Numbers: 2007-0885
1UL1RR024148 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
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:
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Neoplasms