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HoLST-F: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT03832062
Recruitment Status : Unknown
Verified February 2019 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
Ventana Medical Systems
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Oncology Other: Leftover surgical tissue homogenization

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Homogenization of Leftover Surgical Tissue Across Multiple Cancer Types: a Feasibility Study (HoLST-F)
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Intervention Details:
  • Other: Leftover surgical tissue homogenization
    Leftover surgical tissue homogenization


Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
The investigators will be collecting leftover formalin-fixed surgical tissue homogenate and FFPE tumour blocks


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Leftover formalin-fixed tissue from cancer surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832062


Contacts
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Contact: Samra Turajlic 0207 811 8576 Samra.Turajlic@rmh.nhs.uk
Contact: Dilruba Kabir 0207 811 8153 Dilruba.Kabir@rmh.nhs.uk

Locations
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United Kingdom
Royal Marsden Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Ann Gandolfi    02086613903    ann.gandolfi@rmh.nhs.uk   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Ventana Medical Systems
Investigators
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Principal Investigator: Samra Turajlic Royal Marsden NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03832062    
Other Study ID Numbers: CCR 4838
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms