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Head and Neck Early Relapse Detection Study (HERD) (HERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05097625
Recruitment Status : Not yet recruiting
First Posted : October 28, 2021
Last Update Posted : May 23, 2022
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

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.


Condition or disease
Head and Neck Cancer

Detailed Description:

AIMS: We hypothesise that risk of relapse relies on a dynamic interplay between the immune profile, tumour microenvironment, genetic signature and clinicopathological characteristics of the participant receiving treatment. Based on the recruitment of 200 participants within the study, we aim to generate sufficient evidence to guide a multi-analyte-based stratified imaging surveillance/follow up strategy to detect early relapse of cancer and improve survival. We will also develop a biorepository of data across a range of modalities to guide individualised treatment by precision medicine.

OBJECTIVES: The primary objective is to develop and validate a multimodal signature to risk-stratify participants with radically treated head and neck cancer into different surveillance pathways. Non-invasive methods of surveillance, such as blood and saliva tests, will be used to monitor for relapse, with any abnormalities triggering imaging. This will facilitate early detection of relapse and facilitate salvage surgery, leading to better survival outcomes.

DESIGN: This is a prospective cohort study of participants with newly diagnosed locally advanced HPV negative head and neck cancer, deemed to be intermediate or high risk (Figure 2A), referred to secondary care for radical treatment.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Patients With Radically Treated Newly Diagnosed Locally Advanced HPV Negative Head and Neck Cancer to Develop and Validate a Multimodal Signature to Risk-stratify for Recurrence
Estimated Study Start Date : July 15, 2022
Estimated Primary Completion Date : July 15, 2026
Estimated Study Completion Date : July 15, 2026

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Was a multimodal signature developed to risk-stratify participants with locally advanced radically treated head and neck cancer? [ Time Frame: 4 years (data collection period) ]
    Yes or No


Secondary Outcome Measures :
  1. Was a non-invasive method of surveillance successfully developed? [ Time Frame: 4 years (data collection period) ]
    Yes or No


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05097625


Contacts
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Contact: Nicola Muirhead, PhD 02076795279 NCITA.HERD@ucl.ac.uk

Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
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Principal Investigator: Martin Forster, Dr University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT05097625    
Other Study ID Numbers: 277885
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms