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NCT05400239 Clinical Trial

SOTO: Treatment Sensitivity of Organoids to Predict Treatment Outcome

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05400239
Other study ID # SOTO Study 305689
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date June 30, 2025

Study information
Verified date March 2024
Source Guy's and St Thomas' NHS Foundation Trust
Contact Anthony Kong
Phone 0207-848-8302
Email anthony.kong@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Guys Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Treatment Sensitivities To correlate the treatment sensitivities of PDOs with the detection rates of plasma ctDNA (all cohorts) 1 Year
Other Patients Features To assess and correlate the histopathological, genomic and transcriptomic features of patients' samples with PDOs 1 Year
Other PDOs Sensitivities To assess the sensitivities of PDOs to various targeted therapies based on their genomic profiles 1 Year
Other Translational Research Collection of archival tissues, blood samples (for ctDNA and PBMC), saliva (for ctDNA), urine or stool samples for other translational research 1 Year
Primary Successful Organoids To assess the percentage of successful generated organoids from tissues in head and neck cancer patients 1 Year
Secondary Sensitivity To assess the sensitivity of radiotherapy, platinum (cisplatin and/or carboplatin) chemotherapy or cetuximab or their combination in PDOs 1 Year
Secondary Treatment Outcome To correlate the treatment sensitivities of PDOs with the treatment outcome of patients 1 Year
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