Head and Neck Early Relapse Detection Study (HERD)

NCT05097625 | Recruiting

• 1 other identifier: 277885
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone. More than 60% of cases are diagnosed at the locally advanced stage. These patients are treated with radical intent, using a combination of surgery, radiotherapy and/or chemotherapy. Unfortunately 5 in 10 patients relapse within 2 years, with most relapses occurring within the first year since treatment. Unlike many other solid tumours, 80% of relapses occur locoregionally. Salvage surgery offers the best chance of long-term survival for patients with loco-regional recurrence, but this is only possible if the recurrence is amenable to resection. Salvage surgery has been estimated to improve survival outcomes in relapsed cancer by up to 73%. For salvage surgery to be feasible, relapses need to be detected early. Current surveillance strategies have little evidence base, with imaging often driven by clinical symptoms - often when the recurrence is no longer amenable to salvage surgery. With this study, we will address the unmet clinical need to develop a risk-stratified surveillance pathway to enhance detection of early relapse of radically treated head and neck cancer. At present, tumour grade and biomarkers such as HPV status have offered important but insufficient information to guide surveillance strategies.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Was a multimodal signature developed to risk-stratify participants with locally advanced radically treated head and neck cancer?

  Yes or No

  4 years (data collection period)

Secondary Outcomes (1)

• Was a non-invasive method of surveillance successfully developed?

  4 years (data collection period)

Study Arms (2)

High Risk Pathway

Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging

Low Risk Pathway

Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging

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

The study population will be adults, aged 18 years and over with histologically confirmed, locally advanced HNSCC, who are HPV negative and considered of intermediate or high risk, and will be offered radical treatment. This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation.

You may qualify if:

• Histologically confirmed, locally advanced HNSCC, HPV negative considered as intermediate or high risk .
• Offered radical treatment. (This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation).
• Age ≥ 18 years.
• Adequate bone marrow function (nNeutrophils, platelets and haemoglobin grade 0 or 1 according to CTCAE).

You may not qualify if:

• HPV positive disease.
• Participants with concurrent malignancy.
• Confirmed distant metastatic disease on most recent imaging scan.
• Known Hepatitis B, C or HIV infection .
• Contraindications to MRI (including but not limited to cardiac pacemaker, metallic implants, major claustrophobia).
• Pregnant and lactating patients.

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator

Study Sites (1)

Guy's and St Thomas'

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, tumour samples, saliva. Once used, samples will be destroyed, unless a participant has given consent for the remaining samples to be used in future similar studies, in which case these samples will be retained in a biobank.

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Martin Forster, Dr

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Manager

CONTACT

02076709274; NCITA.HERD@ucl.ac.uk

Study Design

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

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 28, 2021
• Study Start: July 12, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)