SOTO: Treatment Sensitivity of Organoids to Predict Treatment Outcome
SOTO Study: Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Head and Neck Squamous Cell Carcinoma (HNSCC) Patients
1 other identifier
observational
60
1 country
1
Brief Summary
In this study, we aim to assess whether Patient Derived Organoids can be used to predict treatment sensitivity in HNSCC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
Typical duration 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
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMarch 21, 2024
March 1, 2024
3.1 years
April 20, 2022
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Successful Organoids
To assess the percentage of successful generated organoids from tissues in head and neck cancer patients
1 Year
Secondary Outcomes (2)
Sensitivity
1 Year
Treatment Outcome
1 Year
Other Outcomes (4)
Treatment Sensitivities
1 Year
Patients Features
1 Year
PDOs Sensitivities
1 Year
- +1 more other outcomes
Study Arms (3)
Cohort 1
Surgically resectable disease, followed by adjuvant radiotherapy +/- chemotherapy
Cohort 2
Primary radiotherapy +/- concurrent chemotherapy
Cohort 3
Recurrent or metastatic HNSCC undergoing platinum based chemotherapy +/- cetuximab
Eligibility Criteria
This is a prospective study with a one-year pilot study aiming to recruit 20 patients, which is the realistic target for year 1. The results from year 1 will be used to estimate the sample size for future prospective observation study
You may qualify if:
- Patients with head and neck squamous cell carcinoma (including oral cavity, oropharynx, paranasal sinuses, hypopharynx or larynx) undergoing curative treatment (primary surgery or radiotherapy) or presenting with recurrent or metastatic cancers
- Age \> 18 years old
You may not qualify if:
- Patients unable to give informed consent e.g. mental disability or vulnerable adults
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guys Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Vasiliadou I, Cattaneo C, Chan PYK, Henley-Smith R, Gregson-Williams H, Collins L, Wojewodka G, Guerrero-Urbano T, Jeannon JP, Connor S, Davis J, Pasto A, Mustapha R, Ng T, Kong A. Correlation of the treatment sensitivity of patient-derived organoids with treatment outcomes in patients with head and neck cancer (SOTO): protocol for a prospective observational study. BMJ Open. 2024 Oct 10;14(10):e084176. doi: 10.1136/bmjopen-2024-084176.
PMID: 39389599DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
April 20, 2022
First Posted
June 1, 2022
Study Start
June 1, 2022
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03