Integrated Molecular Profiling in Advanced Cancers Trial (IMPACT)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition
Breast Cancer
Non-small Cell Lung Cancer
Colorectal Cancer
Genitourinary Cancer
Pancreatobiliary Gastrointestinal Cancer
Upper Aerodigestive Tract Cancer
Gynecological Cancers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Integrated Molecular Profiling in Advanced Cancers Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Archival tumor tissue

1 tube of whole blood


Estimated Enrollment: 500
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505400

Contacts
Contact: PMH Cancer Program 416-946-2993

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Philippe Bedard, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Philippe Bedard, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01505400     History of Changes
Other Study ID Numbers: IMPACT-001
Study First Received: January 4, 2012
Last Updated: December 17, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Molecular profiling
Advanced cancer
Breast cancer
Non-small cell lung cancer
Colorectal cancer
Genitourinary cancer
Pancreatobiliary gastrointestinal cancer
Upper aerodigestive tract cancer
Gynecological cancers
Phase I
Phase I Clinical Trial Candidates

Additional relevant MeSH terms:
Carcinoma, Bronchogenic
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms
Urogenital Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 27, 2014