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Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

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ClinicalTrials.gov Identifier: NCT01703585
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Ontario Institute for Cancer Research
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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 or disease
Colorectal Cancer Breast Cancer Gynecological Cancer Metastatic Eligible for Phase I or Phase II Study Melanoma 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.

Study Type : Observational
Actual Enrollment : 45 participants
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
Actual Study Start Date : October 4, 2012
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Group/Cohort
metastatic breast cancer
metastatic colorectal cancer
metastatic gynecological cancer
metastatic melanoma



Primary Outcome Measures :
  1. Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50% [ Time Frame: 2 years ]
    Sequenom or MiSeq/TSCAP and MiSeq/NGS

  4. 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 ]
    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

  5. 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 ]

Biospecimen Retention:   Samples With DNA
Fresh tumor tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
metastatic breast, colorectal, gynecological cancer or melanoma
Criteria

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.

Information from the National Library of Medicine

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): NCT01703585


Locations
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01703585     History of Changes
Other Study ID Numbers: MATCH-001
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases