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ORganoid GeneratioN Study for Cancer

ORganoid GeneratioN Study for Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05734963
Acronym
ORIGINS
Enrollment
100
Registered
2023-02-21
Start date
2022-04-04
Completion date
2031-04-12
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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

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.

Interventions

GENETICDNA 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

Sponsors

Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Establish patient-derived organoid (PDO) model for cancersTime Frame: Through study completion, expected duration of 9 yearsEstablish patient-derived organoid (PDO) model for cancers

Secondary

MeasureTime frameDescription
To collection contemporaneous biological samples from patients with cancer before and after surgery/biopsy, and again after any adjuvant therapyTime Frame: Through study completion, expected duration of 9 yearsTo 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
To collect tumour tissue to facilitate evolutionary analysis with molecular analysis of multiple regionsTime Frame: Through study completion, expected duration of 9 yearsTo collect tumour tissue to facilitate evolutionary analysis with molecular analysis of multiple regions
Retrieval and analysis of archival primary tissue blocks for comparison where availableTime Frame: Through study completion, expected duration of 9 yearsRetrieval and analysis of archival primary tissue blocks for comparison where available
To establish co-culture tumour/stroma/immune cell modelsTime Frame: Through study completion, expected duration of 9 yearsTo establish co-culture tumour/stroma/immune cell models
To observe associations between molecular and clinicopathological dataTime Frame: Through study completion, expected duration of 9 yearsTo observe associations between molecular and clinicopathological data

Countries

United Kingdom

Contacts

Primary ContactBen O'Leary
ben.oleary@icr.ac.uk02071535337
Backup ContactSarah Burton
origins@rmh.nhs.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026