Value of Analysing Under-utilised Leftover Tissue (VauLT)

Oncology Clinical Trial

— VauLT  

Official title:

Value of Analysing Under-utilised Leftover Tissue (VauLT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832062
• Other study ID #: CCR 4838
• Status: Recruiting
• Start date: September 10, 2018
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Royal Marsden NHS Foundation Trust
• Contact: Samra Turajlic
• Phone: 0207 811 8576
• Email: Samra.Turajlic[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Other:
• Leftover surgical tissue homogenization
Leftover surgical tissue homogenization

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Ventana Medical Systems

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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