Clinical trial NCT01703585: Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples
Official title: A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Breast Cancer
Gynecological Cancer
Metastatic
Eligible for Phase I or Phase II Study
Melanoma Cancer
Keywords: genomic analysis
genome
tumor
tissue
archival
biopsy
core needle
fine needle
DNA
gene
expression
sequencing
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
name: Princess Margaret Hospital, Canada
First posted: 2012-10-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: metastatic breast, colorectal, gynecological cancer or melanoma

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.

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 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.

Primary outcomes:
measure: Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.
timeFrame: 2 years
Secondary outcomes:
measure: 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%
timeFrame: 2 years
measure: 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%
timeFrame: 2 years
measure: Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%
timeFrame: 2 years
measure: 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%
timeFrame: 2 years
measure: Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Lillian Siu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Cancer Centre
name: Bedard Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References: