Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03832062

Value of Analysing Under-utilised Leftover Tissue (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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location status: Recruiting

Location contact

Ann Gandolfi

CONTACT

[email protected]

02086613903

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leftover surgical tissue homogenization

Other

Leftover surgical tissue homogenization

Primary outcomes

  1. 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

  1. Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue

    Time frame: 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

  2. Median time (in minutes) required for the blending (actual homogenization) of each tissue type

    Time frame: 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

  3. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Eleanor Carlyle

CONTACT

Renal&[email protected]

Serena Vanzan

CONTACT

[email protected]

020 3186 5161 ext. 5161

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • Ventana Medical Systems

Registry information

Acronym: VauLT

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2019
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.