Integrated Molecular Profiling in Advanced Cancers Trial (IMPACT)

This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01505400
First received: January 4, 2012
Last updated: December 17, 2012
Last verified: December 2012

January 4, 2012
December 17, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
Molecular profiling data to be made available in patient's electronic medical records. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Genotyping assays including: AKT1, HRAS, AKT2, JAK2, AKT3, KIT, BRAF, KRAS, CDK, MEK1, CTNNB1, MET, EGFR, NOTCH1, ERBB2, NRAS, FGFR1, PDGFRA, FGFR2, PIK3CA, FGFR3, RET, FGFR4, SMO, STK11
Same as current
Complete list of historical versions of study NCT01505400 on ClinicalTrials.gov Archive Site
  • Utilization rates of molecular profiling information [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Including utilization of information for standard regimens or clinical trials of molecularly targeted therapies.
  • Clinical trial accrual rates among patients with available molecular profiling data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Integrated Molecular Profiling in Advanced Cancers Trial
Integrated Molecular Profiling in Advanced Cancers Trial

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.

Biomarkers are specific characteristics of the cancer that may help provide prognostic information (i.e. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.

The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, in order to help their physicians to identify which clinical trials of molecularly targeted therapies may be most appropriate for the patient in the future.

The increasing appreciation and identification of specific somatic mutations and other genetic aberrations that drive cancers leave us on the threshold of a new era of "personalized cancer medicine", in which specific biomarkers will be used to direct targeted agents only to those patients deemed most likely to respond. The potential medical, scientific and economic benefits of such a personalized approach to cancer therapy are immense and self-evident. Yet despite some important advances, only a limited number of approved targeted agents have had their approvals predicated on specific biomarkers of sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations, often present across multiple cancer types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor progression; iii) such genetic aberrations are potentially "druggable" targets; and iv) there are tolerable medicinal compounds that can effectively modulate such targets. A key requirement of this new, personalized approach to anti-cancer therapy is that specific patients must be matched to a particular drug or combination of drugs. Molecular profiling of tumors to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for patients with advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, and gynecological cancers who are candidates for systemic therapy, as well as patients who are phase I trial candidates, in order to help identify which standard regimens or clinical trials of molecularly targeted therapies may be most appropriate for the individual patient.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Archival tumor tissue

1 tube of whole blood

Probability Sample

Advanced cancers (breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, and gynecological cancer) and phase 1 clinical trial candidates

  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Genitourinary Cancer
  • Pancreatobiliary Gastrointestinal Cancer
  • Upper Aerodigestive Tract Cancer
  • Gynecological Cancers
Not Provided
Advanced cancer
Advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, and gynecological cancers; as well as patients who are phase I trial candidates
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histological confirmation of advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, and gynecological carcinomas who are candidates for systemic therapy, as well as patients who are phase I trial candidates.
  • Patient must be ≥ 18 years old.
  • All patients must have signed and dated an informed consent form.
  • All patients must have sufficient archived tumor tissue for molecular profiling.

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact: PMH Cancer Program 416-946-2993
Canada
 
NCT01505400
IMPACT-001
No
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Philippe Bedard, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP