SOTO: Treatment Sensitivity of Organoids to Predict Treatment Outcome

March 20, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guys Hospital
        • Contact:
        • Contact:
          • Ifigenia ifigenia.1.vasiliadou@kcl.ac.uk, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Organoids
Time Frame: 1 Year
To assess the percentage of successful generated organoids from tissues in head and neck cancer patients
1 Year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Sensitivities
Time Frame: 1 Year
To correlate the treatment sensitivities of PDOs with the detection rates of plasma ctDNA (all cohorts)
1 Year
Patients Features
Time Frame: 1 Year
To assess and correlate the histopathological, genomic and transcriptomic features of patients' samples with PDOs
1 Year
PDOs Sensitivities
Time Frame: 1 Year
To assess the sensitivities of PDOs to various targeted therapies based on their genomic profiles
1 Year
Translational Research
Time Frame: 1 Year
Collection of archival tissues, blood samples (for ctDNA and PBMC), saliva (for ctDNA), urine or stool samples for other translational research
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOTO Study 305689

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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