Value of Analysing Under-utilised Leftover Tissue (VauLT)

Recruiting

• Conditions: Oncology

• Registration Number: NCT03832062
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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 Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2028-08-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups	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 Outcome Measures

Name	Time	Method
Median time (in minutes) required for the blending (actual homogenization) of each tissue type	24 Months	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
Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue	24 Months	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
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	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

Trial Locations

Locations (1)

Royal Marsden Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom