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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05400239
Enrollment
60
Registered
2022-06-01
Start date
2022-06-01
Completion date
2025-06-30
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

Interventions

None listed

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Successful Organoids1 YearTo assess the percentage of successful generated organoids from tissues in head and neck cancer patients

Secondary

MeasureTime frameDescription
Sensitivity1 YearTo assess the sensitivity of radiotherapy, platinum (cisplatin and/or carboplatin) chemotherapy or cetuximab or their combination in PDOs
Treatment Outcome1 YearTo correlate the treatment sensitivities of PDOs with the treatment outcome of patients

Other

MeasureTime frameDescription
Treatment Sensitivities1 YearTo correlate the treatment sensitivities of PDOs with the detection rates of plasma ctDNA (all cohorts)
Translational Research1 YearCollection of archival tissues, blood samples (for ctDNA and PBMC), saliva (for ctDNA), urine or stool samples for other translational research
Patients Features1 YearTo assess and correlate the histopathological, genomic and transcriptomic features of patients' samples with PDOs
PDOs Sensitivities1 YearTo assess the sensitivities of PDOs to various targeted therapies based on their genomic profiles

Countries

United Kingdom

Contacts

Primary ContactAnthony Kong
anthony.kong@kcl.ac.uk0207-848-8302
Backup ContactIfigenia Vasiliadou
ifigenia.1.vasiliadou@kcl.ac.uk0207-848-8302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026