NCT03832062

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2018Dec 2028

Study Start

First participant enrolled

September 10, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

January 24, 2019

Last Update Submit

May 14, 2025

Conditions

Outcome Measures

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

    24 Months

Secondary Outcomes (3)

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

    24 Months

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

    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

    24 Months

Interventions

Leftover surgical tissue homogenization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Leftover formalin-fixed tissue from cancer surgery

You may qualify if:

  • 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.

You may not qualify if:

  • Advanced Practitioner in histological dissection deems tumour sample to be inadequate.
  • Leftover surgical tumour tissue greater than 20kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will be collecting leftover formalin-fixed surgical tissue homogenate and FFPE tumour blocks

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Samra Turajlic

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2019

First Posted

February 6, 2019

Study Start

September 10, 2018

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations