CancerORIGINSNCT05734963
ORganoid GeneratioN Study for Cancer
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- DNA sequencing, RNA gene expression analysis, molecular profiling
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2022to 12 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with histologically proven or suspected cancer undergoing an interventional procedure, such as surgery or biopsy
Who may be able to join
- 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
Who cannot join
- Unable to undergo sample collection
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Burton contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital
London
Ben O'Leary, 02071535337, ben.oleary@icr.ac.uk
About this study
ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers
Read the 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.
- Conditions
- Cancer
- Being tested
- DNA sequencing, RNA gene expression analysis, molecular profiling
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA sequencing, RNA gene expression analysis, molecular profilingGenetic
Growth of organoids from tissue samples, collection of tissue, blood and saliva samples for DNA sequencing, RNA gene expression analysis, molecular profiling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: DNA sequencing, RNA gene expression analysis, molecular profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish patient-derived organoid (PDO) model for cancers
Establish patient-derived organoid (PDO) model for cancers
Measured: Time Frame: Through study completion, expected duration of 9 years
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time Frame: Through study completion, expected duration of 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start4 Apr 2022
- Primary completion12 Apr 2031 (estimated)
- Study completion12 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben O'Leary, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734963
- Sponsor's protocol ID
- CCR5396
- Acronym
- ORIGINS
- Status last verified
- Aug 2024
- First submitted
- 8 Feb 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORganoid GeneratioN Study for Cancer
- ClinicalTrials.gov ID
- NCT05734963
- Acronym / sponsor ID
- ORIGINS / CCR5396
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 12 Apr 2031 (estimated)
- Study completion
- 12 Apr 2031 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: DNA sequencing, RNA gene expression analysis, molecular profilingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven or suspected cancer undergoing an interventional procedure, such as surgery or biopsy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to undergo sample collection
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA sequencing, RNA gene expression analysis, molecular profilingGrowth of organoids from tissue samples, collection of tissue, blood and saliva samples for DNA sequencing, RNA gene expression analysis, molecular profiling | Genetic | Group 1 |
Primary outcome
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
5 secondary outcomes
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 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
Retrieval and analysis of archival primary tissue blocks for comparison where available
Time frame: Time Frame: Through study completion, expected duration of 9 years
To establish co-culture tumour/stroma/immune cell models
Time frame: Time Frame: Through study completion, expected duration of 9 years
To observe associations between molecular and clinicopathological data
Time frame: Time Frame: Through study completion, expected duration of 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Burton contact
Ben O'Leary principal investigator
Royal Marsden Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben O'Leary (02071535337, ben.oleary@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish patient-derived organoid (PDO) model for cancers (time frame: Time Frame: Through study completion, expected duration of 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.