SOTO: Treatment Sensitivity of Organoids to Predict Treatment Outcome

Recruiting

• Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT05400239
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

In this study, we aim to assess whether Patient Derived Organoids can be used to predict treatment sensitivity in HNSCC patients.

Detailed Description

This is a prospective observation study to generate patient-derived organoids from patients' samples to assess treatment response and to correlate with patients' treatment outcomes and to collect preliminary data on the ability of PDOs to predict patients' treatment response and whether their radiosensitivity and chemosensitivity can be correlated with their survival outcome.

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-05-27
• Study Start: 2022-06-01
• Study First Posted: 2022-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful Organoids	1 Year	To assess the percentage of successful generated organoids from tissues in head and neck cancer patients

Secondary Outcome Measures

Name	Time	Method
Sensitivity	1 Year	To assess the sensitivity of radiotherapy, platinum (cisplatin and/or carboplatin) chemotherapy or cetuximab or their combination in PDOs
Treatment Outcome	1 Year	To correlate the treatment sensitivities of PDOs with the treatment outcome of patients

Trial Locations

Locations (1)

Guys Hospital; 🇬🇧 London, United Kingdom