SOTO: Treatment Sensitivity of Organoids to Predict Treatment Outcome

Guy's and St Thomas' NHS Foundation Trust

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05400239

SOTO Study 305689

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Cohort 1

Description:

Surgically resectable disease, followed by adjuvant radiotherapy +/- chemotherapy

Cohort 2

Description:

Primary radiotherapy +/- concurrent chemotherapy

Cohort 3

Description:

Recurrent or metastatic HNSCC undergoing platinum based chemotherapy +/- cetuximab