Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Genetic: Circulating tumour DNA dynamics

• Registration Number: NCT05644457
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

DART is an exploratory molecular analysis study to assess potential early biomarkers of treatment response in squamous cell carcinoma of the head and neck (HNSCC)

Detailed Description

If cancer that starts in the head or neck is not suitable for surgery or radiotherapy, then it cannot be cured. Unfortunately, people in this situation have a short life expectancy, with half dying within 12 months. There are treatments available that have helped people in this situation live longer, most recently drugs that stimulate the body's own immune system to attack the cancer, known as 'immunotherapy'. Some people do very well on these treatments, living many years, while the same treatments offer no benefit to others - it is not known why. This study is looking at collecting samples of a person's cancer, along with other body fluids, particularly blood and saliva, to see if the investigators can track changes in blood and saliva that happen in a person's cancer while they are receiving treatment. Additionally, samples of the cancer will be used to see if they can be grown in the laboratory to test growth behaviour and how well different treatments work.

The investigators will ask people being treated for incurable cancer that started in the head and neck for permission to collect their blood and saliva, along with samples of their cancer tissue, while they are having treatment. Nearly all patients will require a sample of their cancer tissue taken with a needle (a 'biopsy') anyway, and tissue samples can be taken as part of this process. Similarly, the safe administration of cancer drugs requires blood tests before every course of treatment, and research bloods can be taken from the same blood draw. A small number of people will be asked whether they give their permission for an extra biopsy of their cancer to allow further comparisons in the laboratory.

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 18 years or older
• Patients with histologically confirmed cancer of the head and neck with evidence of recurrent or locally advanced cancer not suitable for treatment with curative intent, or metastatic disease.
• Receiving immunotherapy
• Ability to give informed consent for biological sample collection.

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Exclusion Criteria

• Unable to undergo serial sample collection
• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving systemic therapies for cancers of the head and neck	Circulating tumour DNA dynamics	Patients undergoing systemic therapy for recurrent, metastatic, or locally advanced cancer of the head and neck not suitable for treatment with curative intent. A biological research study involving the collection of blood, tumour tissue, saliva, and other body fluids routinely examined during cancer care (e.g. cerebrospinal fluid (CSF), ascites, urine, stool or pleural fluids).

Primary Outcome Measures

Name	Time	Method
The level of circulating tumour DNA pre-treatment will be descriptively compared to the levels detected at subsequent time points	Through study completion, expected duration of 5 years

Secondary Outcome Measures

Name	Time	Method
To correlate assays with clinicopathological data.	Through study completion, expected duration of 5 years
To collect longitudinal biological samples, including blood, saliva and tissue, for molecular profiling	Through study completion, expected duration of 5 years	Molecular profiling to include extraction of DNA for sequencing, RNA for gene expression analysis, expansion of peripheral blood mononuclear cells (PBMCs), and proteins for proteomic studies
To collect tumour tissue to facilitate molecular analysis of recurrent or metastatic cancers of the head and neck.	Through study completion, expected duration of 5 years
Retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites.	Through study completion, expected duration of 5 years
To isolate live tumour and immune cells for studies of therapy resistance and biology in cancers of the head and neck.	Through study completion, expected duration of 5 years

Trial Locations

Locations (1)

The Royal Marsden Hospital; 🇬🇧 London, United Kingdom