Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Health Network, Toronto
Sponsor:
Collaborators:
Ontario Institute for Cancer Research
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01703585
First received: October 5, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition
Colorectal Cancer
Breast Cancer
Gynecological Cancer
Metastatic
Eligible for Phase I or Phase II Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90% [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50% [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50% [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Sequenom or MiSeq/TSCAP and MiSeq/NGS

  • Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90% [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks

  • Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30% [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Fresh tumor tissue


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
metastatic breast cancer
metastatic colorectal cancer
metastatic gynecological cancer

Detailed 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.

  Eligibility

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

metastatic metastatic breast, colorectal or gynecological cancer

Criteria

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.
  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: NCT01703585

Contacts
Contact: Celeste Yu, MSc 416-946-4501 ext 4277 celeste.yu@uhn.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Lillian Siu, MD         
Principal Investigator: Bedard Philippe, MD         
Sponsors and Collaborators
University Health Network, Toronto
Ontario Institute for Cancer Research
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre
Principal Investigator: Bedard Philippe, MD Princess Margaret Cancer Centre
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01703585     History of Changes
Other Study ID Numbers: MATCH-001
Study First Received: October 5, 2012
Last Updated: December 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
genomic analysis
genome
tumor
tissue
archival
biopsy
core needle
fine needle
DNA
gene
expression
sequencing

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014