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In this study, we aim to assess whether Patient Derived Organoids can be used to predict treatment sensitivity in HNSCC patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful Organoids | To assess the percentage of successful generated organoids from tissues in head and neck cancer patients | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | To assess the sensitivity of radiotherapy, platinum (cisplatin and/or carboplatin) chemotherapy or cetuximab or their combination in PDOs | 1 Year |
| Treatment Outcome | To correlate the treatment sensitivities of PDOs with the treatment outcome of patients |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Sensitivities | To correlate the treatment sensitivities of PDOs with the detection rates of plasma ctDNA (all cohorts) | 1 Year |
| Patients Features | To assess and correlate the histopathological, genomic and transcriptomic features of patients' samples with PDOs |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony Kong | Contact | 0207-848-8302 | anthony.kong@kcl.ac.uk | |
| Ifigenia Vasiliadou | Contact | 0207-848-8302 | ifigenia.1.vasiliadou@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys Hospital | Recruiting | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389599 | Derived | Vasiliadou I, Cattaneo C, Chan PYK, Henley-Smith R, Gregson-Williams H, Collins L, Wojewodka G, Guerrero-Urbano T, Jeannon JP, Connor S, Davis J, Pasto A, Mustapha R, Ng T, Kong A. Correlation of the treatment sensitivity of patient-derived organoids with treatment outcomes in patients with head and neck cancer (SOTO): protocol for a prospective observational study. BMJ Open. 2024 Oct 10;14(10):e084176. doi: 10.1136/bmjopen-2024-084176. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2022 | May 19, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 1 Year |
| 1 Year |
| PDOs Sensitivities | To assess the sensitivities of PDOs to various targeted therapies based on their genomic profiles | 1 Year |
| 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 |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |