Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Study Overview
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Brief Summary
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Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Detailed Description
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This study supports the collection of tumor specimens for CLIA-certified genomic testing and research testing in parallel. CLIA-certified tests have established measurements of accuracy and precision which allow for return of results. This study does not involve treatment, only testing, which could be used to meet eligibility criteria in other trials.

Official Title
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Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Conditions
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Cancer

Intervention / Treatment
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* Other: Biospecimen collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A histologically or cytologically confirmed diagnosis of cancer Patients with any malignancy. Patients must have tumor suitable for research tumor biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue OR If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation. OR Patients are undergoing standard of care surgeries or procedures where fresh specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes. Procedure-specific signed informed consent prior to initiation of any study-related procedures. Women and minorities are included in this protocol. Patients with multiple malignancies remain eligible. Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible. Exclusion Criteria: It is the enrolling study physicians discretion to decide if a patient is not fit enough to undergo tissue biopsy. Patients who are incarcerated are not eligible to participate.

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 |
| --- | --- |
| Advanced Cancer Patients<br>Individuals with advanced or refractory cancer must be identified by study personnel or their treating physician, deemed eligible for this study, and voluntarily agree to be enrolled in this protocol through an informed consent. Biospecimen collection includes a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear. | Other: Biospecimen collection<br>* Specimens to be collected include a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants receiving new therapy based on study findings | Impact on clinical care | Up to 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of days to return results | Determine average number of days for return of results | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Genomics, Tumor Sequencing