Value of Analysing Under-utilised Leftover Tissue (VauLT) (VauLT)

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology
• Intervention / Treatment: Other: Leftover surgical tissue homogenization

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Serena Vanzan; Phone Number: 5161 020 3186 5161; Email: vault@rmh.nhs.uk
• Study Contact Backup: Name: Eleanor Carlyle; Email: Renal&Melanoma.researchteam@rmh.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital NHS Foundation Trust
    • Contact: Ann Gandolfi; Phone Number: 02086613903; Email: ann.gandolfi@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Leftover formalin-fixed tissue from cancer surgery

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: Ventana Medical Systems
• Investigators: Study Chair: Samra Turajlic, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CCR 4838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No