Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metastatic breast cancer<br> | |
| metastatic colorectal cancer<br> | |
| metastatic gynecological cancer<br> | |
| metastatic melanoma<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | Sequenom or MiSeq/TSCAP and MiSeq/NGS | 2 years | 
| 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% | 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 | 2 years | 
| Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30% |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genomic analysis, genome, tumor, tissue, archival, biopsy, core needle, fine needle, DNA, gene, expression, sequencing