Liquid Biopsy for Early DiagNosis of Squamous Cell Carcinoma of the HeAd and NeCk rEgion

NCT05645783 | Recruiting

• 1 other identifier: CCR5610
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

The 5-year survival for Head and Neck squamous cell carcinoma (HNSCC) across all TNM stage groups is approximately 50%. Patients who are present with stage I \& II disease have significantly better survival. When a patient presents to their general practitioner (GP) with symptoms suggestive of HNSCC, they may be referred for urgent specialist input through the suspected cancer referral (SCR) pathway, which include dedicated neck lump clinics. HNSCC is known to shed fragments of DNA, called circulating tumor DNA (ctDNA) into the bloodstream. The investigators have developed novel ultra-sensitive (\>90% sensitivity) next generation sequencing (NGS) assay for circulating HPV DNA in patients with non-metastatic locally advanced head and neck cancer. The use of ultra-sensitive NGS assay for detection of ctDNA using a simple blood test (liquid biopsy) holds a great promise for cancer screening and early diagnosis and can lead to better survival results and less disease burden. With a quicker turnaround (1-2 weeks), the liquid biopsy can help expedite the patient journey through the cancer pathways reducing the incidence of cancer target breaches. In order to design studies to test this hypothesis the investigators require preliminary data quantifying sensitivity and specificity of the assay in this setting.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Measure the sensitivity of the NGS assay for detection of ctDNA in patients with early HNSCC

  1 year

Secondary Outcomes (1)

• Measure the specificity of the NGS assay for detection of ctDNA at baseline in patients with early HNSCC

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the neck lump clinics via the SCR pathway, who are classified as high risk and referred for an USFNA.

You may qualify if:

• Patients referred for an Ultrasound guided fine needle aspiration (USFNA) in the neck lump clinic

You may not qualify if:

• Patient found to have a lump in the thyroid gland at the time of USFNA
• Unable to give informed consent for biological sample collection
• Unable to safely participate in clinic sample collection

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (2)

Kingston Hospital Foundation Trust

Kingston upon Thames, KT27QB, United Kingdom

RECRUITING

Northwick Park Hospital

London, HA13UJ, United Kingdom

NOT YET RECRUITING

Related Publications (3)

• https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/head-and-neck-cancers.

  BACKGROUND

• Lee JY, Garcia-Murillas I, Cutts RJ, De Castro DG, Grove L, Hurley T, Wang F, Nutting C, Newbold K, Harrington K, Turner N, Bhide S. Predicting response to radical (chemo)radiotherapy with circulating HPV DNA in locally advanced head and neck squamous carcinoma. Br J Cancer. 2017 Sep 5;117(6):876-883. doi: 10.1038/bjc.2017.258. Epub 2017 Aug 15.

  PMID: 28809864 BACKGROUND

• Lam WKJ, Jiang P, Chan KCA, Cheng SH, Zhang H, Peng W, Tse OYO, Tong YK, Gai W, Zee BCY, Ma BBY, Hui EP, Chan ATC, Woo JKS, Chiu RWK, Lo YMD. Sequencing-based counting and size profiling of plasma Epstein-Barr virus DNA enhance population screening of nasopharyngeal carcinoma. Proc Natl Acad Sci U S A. 2018 May 29;115(22):E5115-E5124. doi: 10.1073/pnas.1804184115. Epub 2018 May 14.

  PMID: 29760067 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A 20ml blood sample (2x 10ml blood collection tube, Streck or other appropriate) for plasma extraction and collection of buffy coat or PBMCs will be taken.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Shreerang Bhide

CONTACT

02073528171; Shreerang.Bhide@rmh.nhs.uk

Sarah Burton

CONTACT

02073528171; enhance@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: December 12, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

GB (2)