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NCT Number: NCT05644457

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

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)

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden Hospital

London, United Kingdom

Location status: Recruiting

Location contact

Ben O'Leary

CONTACT

[email protected]

02071535337

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The level of circulating tumour DNA pre-treatment will be descriptively compared to the levels detected at subsequent time points

    Time frame: Through study completion, expected duration of 5 years

Secondary outcomes

  1. To collect longitudinal biological samples, including blood, saliva and tissue, for molecular profiling

    Time frame: 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

  2. To collect tumour tissue to facilitate molecular analysis of recurrent or metastatic cancers of the head and neck.

    Time frame: Through study completion, expected duration of 5 years

  3. To isolate live tumour and immune cells for studies of therapy resistance and biology in cancers of the head and neck.

    Time frame: Through study completion, expected duration of 5 years

  4. Retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites.

    Time frame: Through study completion, expected duration of 5 years

  5. To correlate assays with clinicopathological data.

    Time frame: Through study completion, expected duration of 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ben O'Leary

CONTACT

[email protected]

02071535337

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Acronym: DART

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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