Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

University Health Network, Toronto

Status: Completed

Conditions: Breast Cancer; Melanoma Cancer; Gynecological Cancer; Metastatic; Colorectal Cancer; Eligible for Phase I or Phase II Study

Study type: Observational

Funder types: Other

Identifiers

NCT01703585

MATCH-001

Details and patient eligibility

About

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

Full description

As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy.
• At least one biopsiable lesion deemed medically accessible and safe to biopsy.
• Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point.
• Fulfills local institution's laboratory parameters for tumor biopsy.
• Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion criteria

• Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
• Any contraindication to undergoing a biopsy procedure.

Trial design

45 participants in 4 patient groups

metastatic breast cancer

metastatic colorectal cancer

metastatic gynecological cancer

metastatic melanoma