ORganoid GeneratioN Study for Cancer
ORIGINS
1 other identifier
observational
100
1 country
1
Brief Summary
ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2022
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 12, 2031
August 9, 2024
August 1, 2024
9 years
February 8, 2023
August 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
To collection contemporaneous biological samples from patients with cancer before and after surgery/biopsy, and again after any adjuvant therapy
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: Through study completion, expected duration of 9 years
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
Time Frame: Through study completion, expected duration of 9 years
To observe associations between molecular and clinicopathological data
Time Frame: Through study completion, expected duration of 9 years
Study Arms (1)
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
Interventions
Growth of organoids from tissue samples, collection of tissue, blood and saliva samples for DNA sequencing, RNA gene expression analysis, molecular profiling
Eligibility Criteria
Patients with histologically proven or suspected cancer undergoing an interventional procedure, such as surgery or biopsy
You may qualify if:
- 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
You may not qualify if:
- Unable to undergo sample collection
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Royal Marsden Hospital
London, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben O'Leary
Royal Marsden Hospital NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 21, 2023
Study Start
April 4, 2022
Primary Completion (Estimated)
April 12, 2031
Study Completion (Estimated)
April 12, 2031
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share