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A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Breast Cancer, Gynecological Cancer, Metastatic, Eligible for Phase I or Phase II Study

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Trial Information

A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity


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.


Inclusion Criteria:



- Age ≥ 18 years.

- Histological or cytological proof of either metastatic breast, colorectal or
gynecological 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Cancer Centre

Authority:

Canada: Ethics Review Committee

Study ID:

MATCH-001

NCT ID:

NCT01703585

Start Date:

October 2012

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer
  • Breast Cancer
  • Gynecological Cancer
  • Metastatic
  • Eligible for Phase I or Phase II Study
  • genomic analysis
  • genome
  • tumor
  • tissue
  • archival
  • biopsy
  • core needle
  • fine needle
  • DNA
  • gene
  • expression
  • sequencing
  • Breast Neoplasms
  • Colorectal Neoplasms

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