Value of Analysing Under-utilised Leftover Tissue (VauLT)
ConditionOncology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Advanced Practitioner in histological dissection deems tumour sample to be inadequate.
Leftover surgical tumour tissue greater than 20kg.
Trial population
Leftover formalin-fixed tissue from cancer surgery
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Leftover surgical tissue homogenization
Other interventionLeftover surgical tissue homogenization
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
24 MonthsSecondary outcomes
1
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
Time frame
24 Months2
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
Time frame
24 Months3
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
Time frame
24 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal Marsden NHS Foundation Trust
Lead sponsor
Ventana Medical Systems
Collaborator
Source ClinicalTrials.gov