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

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT05644457

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Circulating tumour DNA dynamics (genetic)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
Circulating tumour DNA dynamics — genetic: Circulating tumour DNA (ctDNA) can be identified in patients with a wide variety of cancers and has been shown to allow early prediction of disease relapse after treatment with curative intent in HNSCC.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
50
Started
2022-03-09
Last checked
2024-08

Plain English Summary

What is this study?

  • • Testing a new treatment for head and neck cancer
  • • Clinical study - 50 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with head and neck cancer

Where?

  • • London - The Royal Marsden Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

More detail

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.

Head and Neck Cancer

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age 18 years or older
  • ✓Patients with confirmed by a biopsy cancer of the head and neck with evidence of recurrent or that has grown locally...
  • ✓Receiving treatment that helps your immune system fight cancer
  • ✓Ability to give agreement to take part for biological sample collection.

Who cannot take part

  • ✗Unable to undergo serial sample collection
  • ✗Pregnancy
See the full criteria
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. Exclusion Criteria: * Unable to undergo serial sample collection * Pregnancy

Where Is This Study? (1 UK site)

The Royal Marsden Hospital

London, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Ben O'Leary

Sponsor contact

CONTACT

02071535337 ben.oleary@icr.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-08