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

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

NCT ID: NCT05645783

Condition: Head and Neck Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Detailed description: 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. Majority of the patients diagnosed via the SCR pathway present with Stage III &IV disease, which has a direct impact on outcomes. HNSCC is classified as an uncommon cancer and as such diagnosis and treatment is undertaken in specialist tertiary referral centres. The care of patients initially diagnosed with HNSCC in smaller secondary care hospitals is transferred to these specialist tertiary referral centres via the Inter Trust Transfer (ITT). ITT can introduce delays in treatment pathways resulting in a failure to achieve cancer treatment targets. Southwest London HNSCC diagnostic pathway review which was undertaken in February 2021 demonstrated that 40% of ITTs received were greater than 38 days after referral and that 68% of the 62 day target breaches were in patients with ITT. 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 investigator's current work involves ctDNA detection to cover the spectrum of genetic alterations in HNC using a single sequencing workflow to detect copy number aberrations (CNAs), HPV DNA (to cover 99.9% of HNC related HPV) and somatic mutations. 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. This has been proven in proof of principle studies in nasopharyngeal cancer (Chan N Engl J Med 2017; 377:513-522). Furthermore, this test can be administered in smaller secondary care hospitals in parallel to the ITT. 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Patients referred for an Ultrasound guided fine needle aspiration (USFNA) in the neck lump clinic Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kingston Hospital Foundation Trust

Address:
City: Kingston Upon Thames
Zip: KT27QB
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Enyi Ofo
Email: enyi.ofo@nhs.net

Investigator:
Last name: Enyi Ofo
Email: Principal Investigator

Facility:
Name: Northwick Park Hospital

Address:
City: London
Zip: HA13UJ
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Liu Zi-Wei
Email: liu.ziwei@nhs.net

Investigator:
Last name: Liu Zi-Wei
Email: Principal Investigator

Start date: February 1, 2023

Completion date: December 2024

Lead sponsor:
Agency: Royal Marsden NHS Foundation Trust
Agency class: Other

Source: Royal Marsden NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05645783