HoLST-F: A Feasibility Study

Study Overview
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Brief Summary
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Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to therapeutic resistance. It also limits the ability of small samples to represent the whole tumour, having implications for diagnosis, molecular analysis and understanding of the tumour immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of that required for diagnosistic purposes, one may create a more representative sample for analysis.

Detailed Description
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In order to establish the feasibility of homogenization as a potential companion diagnostic tool, our study aims to 1) evaluate how many surgical cases have left over tissue amenable to homogenization and 2) pilot homogenization across multiple tumour types. The molecular profile of the homogenate will be compared to that obtained from the diagnostic specimen using next generation sequencing techniques.

Official Title
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Homogenization of Leftover Surgical Tissue Across Multiple Cancer Types: a Feasibility Study (HoLST-F)

Conditions
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Oncology

Intervention / Treatment
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* Other: Leftover surgical tissue homogenization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Leftover formalin-fixed tissue (ie that would be otherwise discarded by histopathology) from cancer surgery. Tissues for Research consent has been provided. Patient age >18yo. Minimum of 1 gram of residual tumour remaining in leftover surgical tissue Minimum of 1 gram of normal tissue present. Exclusion Criteria: Advanced Practitioner in histological dissection deems tumour sample to be inadequate. Leftover surgical tumour tissue greater than 20kg.

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

| Intervention/Treatment |
| --- |
|Other: Leftover surgical tissue homogenization|Leftover surgical tissue homogenization|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups | Surgical lists will be generated providing cases of all surgeries containing excess tumour tissue. The tissue will be dissected and weighed to determine if tumour tissue available is greater than 1g | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue | The time taken to dissected will be documented by recording the start and stop times of the procedure and noting this on a source document | 24 Months | 
| Median time (in minutes) required for the blending (actual homogenization) of each tissue type | The time taken to homogenize will be documented by recording the start and stop times of the procedure and noting this on a source document | 24 Months | 
| Difference in molecular profile between the diagnostic block and the homogenized sample. This will be measured by next generation sequencing techniques across the 8 primary tumour types | The molecular profile of the diagnostic block will be determined by next generation sequencing and the same will be done with the homogenized sample. This will allow a comparison to be made between the two sample types and determine the difference in molecular profile between the two | 24 Months |