Clinical trial · Observational
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
NCT05400239CI-TRIAL-00075269unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, we aim to assess whether Patient Derived Organoids can be used to predict treatment sensitivity in HNSCC patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1
- description
- Surgically resectable disease, followed by adjuvant radiotherapy +/- chemotherapy
- label
- Cohort 2
- description
- Primary radiotherapy +/- concurrent chemotherapy
- label
- Cohort 3
- description
- Recurrent or metastatic HNSCC undergoing platinum based chemotherapy +/- cetuximab
Primary outcomes (1)
- measure
- Successful Organoids
- timeFrame
- 1 Year
- description
- To assess the percentage of successful generated organoids from tissues in head and neck cancer patients
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients unable to give informed consent e.g. mental disability or vulnerable adults
References
Publications (1)
- DERIVEDVasiliadou 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 39389599