Value of Analysing Under-utilised Leftover Tissue (VauLT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Leftover surgical tissue homogenization.
- Who it may be relevant to
- Registry conditions: Oncology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Leftover surgical tissue homogenization
Leftover surgical tissue homogenization
Primary outcome measures
- The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups [Time frame: 24 Months]
Secondary outcome measures (3)
- Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue [Time frame: 24 Months]
- Median time (in minutes) required for the blending (actual homogenization) of each tissue type [Time frame: 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 [Time frame: 24 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Royal Marsden Hospital NHS Foundation Trust — London
Identifiers
NCT: NCT03832062 · CCR 4838