Clinical trial NCT01505400: Integrated Molecular Profiling in Advanced Cancers Trial
Official title: Integrated Molecular Profiling in Advanced Cancers Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Keywords: 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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2012-01-06
Enrollment: 3026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced cancers (breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas) and phase 1 clinical trial candidates

Brief summary: 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.

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 criteria: 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:

* None

Primary outcomes:
measure: Molecular profiling data to be made available in patient's electronic medical records.
timeFrame: 1 month
Secondary outcomes:
measure: Utilization rates of molecular profiling information
timeFrame: 1 year
measure: Clinical trial accrual rates among patients with available molecular profiling data
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Philippe Bedard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma LX, Espin-Garcia O, Bedard PL, Stockley T, Prince R, Mete O, Krzyzanowska MK. Clinical Application of Next-Generation Sequencing in Advanced Thyroid Cancers. Thyroid. 2022 Jun;32(6):657-666. doi: 10.1089/thy.2021.0542. Epub 2022 May 16.
citation: Stockley TL, Oza AM, Berman HK, Leighl NB, Knox JJ, Shepherd FA, Chen EX, Krzyzanowska MK, Dhani N, Joshua AM, Tsao MS, Serra S, Clarke B, Roehrl MH, Zhang T, Sukhai MA, Califaretti N, Trinkaus M, Shaw P, van der Kwast T, Wang L, Virtanen C, Kim RH, Razak AR, Hansen AR, Yu C, Pugh TJ, Kamel-Reid S, Siu LL, Bedard PL. Molecular profiling of advanced solid tumors and patient outcomes with genotype-matched clinical trials: the Princess Margaret IMPACT/COMPACT trial. Genome Med. 2016 Oct 25;8(1):109. doi: 10.1186/s13073-016-0364-2.