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NCT Number: NCT05734963

ORganoid GeneratioN Study for Cancer

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden Hospital

London, United Kingdom

Location status: Recruiting

Location contact

Ben O'Leary

CONTACT

[email protected]

02071535337

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA sequencing, RNA gene expression analysis, molecular profiling

Genetic

Growth of organoids from tissue samples, collection of tissue, blood and saliva samples for DNA sequencing, RNA gene expression analysis, molecular profiling

Primary outcomes

  1. Establish patient-derived organoid (PDO) model for cancers

    Time frame: Time Frame: Through study completion, expected duration of 9 years

    Establish patient-derived organoid (PDO) model for cancers

Secondary outcomes

  1. To collection contemporaneous biological samples from patients with cancer before and after surgery/biopsy, and again after any adjuvant therapy

    Time frame: Time Frame: Through study completion, expected duration of 9 years

    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

  2. To collect tumour tissue to facilitate evolutionary analysis with molecular analysis of multiple regions

    Time frame: Time Frame: Through study completion, expected duration of 9 years

    To collect tumour tissue to facilitate evolutionary analysis with molecular analysis of multiple regions

  3. Retrieval and analysis of archival primary tissue blocks for comparison where available

    Time frame: Time Frame: Through study completion, expected duration of 9 years

    Retrieval and analysis of archival primary tissue blocks for comparison where available

  4. To establish co-culture tumour/stroma/immune cell models

    Time frame: Time Frame: Through study completion, expected duration of 9 years

    To establish co-culture tumour/stroma/immune cell models

  5. To observe associations between molecular and clinicopathological data

    Time frame: Time Frame: Through study completion, expected duration of 9 years

    To observe associations between molecular and clinicopathological data

Study contacts

Contact information is provided by the study sponsor or research team.

Ben O'Leary

CONTACT

[email protected]

02071535337

Sarah Burton

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Acronym: ORIGINS

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Feb 21, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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