Integrated Molecular Profiling in Advanced Cancers Trial (IMPACT)
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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 Melanoma Cancers Rare Cancers Unknown Primary Cancers |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Integrated Molecular Profiling in Advanced Cancers Trial |
- Molecular profiling data to be made available in patient's electronic medical records. [ Time Frame: 1 month ]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
- Utilization rates of molecular profiling information [ Time Frame: 1 year ]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 ]
Biospecimen Retention: Samples With DNA
Archival tumor tissue
1 tube of whole blood
| Enrollment: | 3026 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (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, gynecological, melanoma, unknown primary, and rare carcinomas; 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, gynecological, melanoma, unknown primary, and rare carcinomas, 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
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients with histological confirmation of advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas who are candidates for systemic therapy, as well as patients who are phase I trial candidates.
- Patient must be ≥ 18 years old.
- Patient's ECOG performance status equal to 0 or 1.
- All patients must have signed and dated an informed consent form.
- All patients must have sufficient archived tumor tissue for molecular profiling.
Exclusion Criteria:
Contacts and Locations
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): NCT01505400
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Philippe Bedard, MD | Princess Margaret Hospital, Canada |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01505400 History of Changes |
| Other Study ID Numbers: |
IMPACT-001 |
| First Submitted: | January 4, 2012 |
| First Posted: | January 6, 2012 |
| Last Update Posted: | August 22, 2016 |
| Last Verified: | August 2016 |
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 melanoma cancer rare cancer unknown primary cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Melanoma Colorectal Neoplasms Gastrointestinal Neoplasms Urogenital Neoplasms Neoplasms, Unknown Primary Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Intestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasm Metastasis Neoplastic Processes |