Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01703585

Enrollment

Registered

2012-10-10

Start date

2012-10-04

Completion date

2018-05-01

Last updated

2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

genomic analysis, genome, tumor, tissue, archival, biopsy, core needle, fine needle, DNA, gene, expression, sequencing

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.	2 years

Secondary

Measure	Time frame	Description
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%	2 years	—
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%	2 years	—
Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%	2 years	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%	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
Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%	2 years	—

Countries

Canada

Outcome results