Value of Analysing Under-utilised Leftover Tissue (VauLT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups
Time Frame: 24 Months
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
Secondary Outcomes
- Median time (in minutes) required for the blending (actual homogenization) of each tissue type(24 Months)
- Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue(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(24 Months)