NCT05734963

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
59mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Apr 2022Apr 2031

Study Start

First participant enrolled

April 4, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2031

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

9 years

First QC Date

February 8, 2023

Last Update Submit

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

Genetic: DNA sequencing, RNA gene expression analysis, molecular profiling

Interventions

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Sequence Analysis, DNA

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • Ben O'Leary

    Royal Marsden Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Burton

CONTACT

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

Locations