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Value of Analysing Under-utilised Leftover Tissue (VauLT)

Value of Analysing Under-utilised Leftover Tissue (VauLT)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03832062
Acronym
VauLT
Enrollment
800
Registered
2019-02-06
Start date
2018-09-10
Completion date
2028-12-31
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

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.

Interventions

OTHERLeftover surgical tissue homogenization

Leftover surgical tissue homogenization

Sponsors

Ventana Medical Systems
CollaboratorUNKNOWN
Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Leftover formalin-fixed tissue (ie that would be otherwise discarded by histopathology) from cancer surgery. 2. Tissues for Research consent has been provided. 3. Patient age \>18yo. 4. Minimum of 1 gram of residual tumour remaining in leftover surgical tissue 5. Minimum of 1 gram of normal tissue present.

Exclusion criteria

1. Advanced Practitioner in histological dissection deems tumour sample to be inadequate. 2. Leftover surgical tumour tissue greater than 20kg.

Design outcomes

Primary

MeasureTime frameDescription
The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups24 MonthsSurgical 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

MeasureTime frameDescription
Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue24 MonthsThe time taken to dissected will be documented by recording the start and stop times of the procedure and noting this on a source document
Median time (in minutes) required for the blending (actual homogenization) of each tissue type24 MonthsThe time taken to homogenize will be documented by recording the start and stop times of the procedure and noting this on a source document
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 types24 MonthsThe 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

Countries

United Kingdom

Contacts

Primary ContactSerena Vanzan
vault@rmh.nhs.uk020 3186 5161
Backup ContactEleanor Carlyle
Renal&Melanoma.researchteam@rmh.nhs.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026