ORganoid GeneratioN Study for Cancer (ORIGINS)

ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Genetic: DNA sequencing, RNA gene expression analysis, molecular profiling

Detailed Description

People who develop cancer can often be cured if they are suitable for surgery or radiotherapy. However, a proportion of these cancers return, at which point the available treatment options are often not very effective. Our understanding of the biology of many cancers is limited, and we don't understand why some cancers are cured by surgery or radiotherapy and some are not. A better understanding of the biology of cancers could help develop new treatments, or improvements to current treatments, and this might increase the number of patients who can be cured of their disease.

One way to improve the understanding we have of the biology is to look in detail at cancer samples taken from the from patients. The problem with this is that often samples are small, and the tumour tissue sample itself already dead once removed from where it was growing, which can limit the analyses that are possible. A potential solution for this is to take cancer tissue from patients and try to directly grow the cells in the laboratory. Keeping the cancer cells alive in the laboratory can be difficult but has been shown to be possible in a number of different types of cancer. This kind of model is sometimes known as an "organoid". If successfully established, it means more tests can be done to find out how the cancer is working.

This study is looking at collecting samples of a person's cancer to see if we can develop these models from patients being treated for different cancers. We will ask people who are having surgery for cancer whether we can take samples from their tumour to try and achieve this. Some additional blood tests will be taken alongside the usual blood tests before and after surgery, without an additional blood draw, and before and again after any adjuvant therapy is completed. A collection of saliva will also be requested at these times and we will ask people whether they are happy for us to collect any previous tissue samples, or nay that are subsequently collected when they are being followed up, to allow comparison with the samples collected as part of this study.

The main goal of this study is to see if organoids can be established in our laboratories. If these models are successfully established, we will compare them to the original tumour to check they are a good match biologically. After this we can use them to understand how the cancer works and try out new treatments.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ben O'Leary; Phone Number: 02071535337; Email: ben.oleary@icr.ac.uk
• Study Contact Backup: Name: Sarah Burton; Email: origins@rmh.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • The Royal Marsden Hospital
    • Contact: Ben O'Leary; Phone Number: 02071535337; Email: ben.oleary@icr.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically proven or suspected cancer undergoing an interventional procedure, such as surgery or biopsy

Description

Inclusion Criteria:

• Age 18 years or older
• Patients with histologically proven or suspected cancer undergoing an interventional procedure, such as surgery or biopsy
• Ability to give informed consent for biological sample collection

Exclusion Criteria:

• Unable to undergo sample collection
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients with histologically confirmed cancer Tissue, blood and saliva samples collected before and after surgery and before and after any adjuvant therapy. Molecular profiling, DNA sequencing, gene expression analysis	Genetic: DNA sequencing, RNA gene expression analysis, molecular profiling; Growth of organoids from tissue samples, collection of tissue, blood and saliva samples for DNA sequencing, RNA gene expression analysis, molecular profiling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish patient-derived organoid (PDO) model for cancers	Establish patient-derived organoid (PDO) model for cancers	Time Frame: Through study completion, expected duration of 9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collection contemporaneous biological samples from patients with cancer before and after surgery/biopsy, and again after any adjuvant therapy	To collection contemporaneous biological samples from patients with cancer before and after surgery/biopsy, and again after any adjuvant therapy - including blood, saliva and tissue, for molecular profiling, including extraction of DNA for sequencing, RNA	Time Frame: Through study completion, expected duration of 9 years
To collect tumour tissue to facilitate evolutionary analysis with molecular analysis of multiple regions	To collect tumour tissue to facilitate evolutionary analysis with molecular analysis of multiple regions	Time Frame: Through study completion, expected duration of 9 years
Retrieval and analysis of archival primary tissue blocks for comparison where available	Retrieval and analysis of archival primary tissue blocks for comparison where available	Time Frame: Through study completion, expected duration of 9 years
To establish co-culture tumour/stroma/immune cell models	To establish co-culture tumour/stroma/immune cell models	Time Frame: Through study completion, expected duration of 9 years
To observe associations between molecular and clinicopathological data	To observe associations between molecular and clinicopathological data	Time Frame: Through study completion, expected duration of 9 years

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Ben O'Leary, Royal Marsden Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): April 12, 2031
• Study Completion (Estimated): April 12, 2031

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CCR5396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No