To hear about similar clinical trials, please enter your email below
Trial Title:
Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck
NCT ID:
NCT05644457
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Circulating tumour DNA dynamics
Description:
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.
Arm group label:
Patients receiving systemic therapies for cancers of the head and neck
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.
Criteria for eligibility:
Study pop:
Patients undergoing systemic therapy for recurrent, metastatic, or locally advanced
cancer of the head and neck not suitable for treatment with curative intent.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Royal Marsden Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ben O'Leary
Phone:
02071535337
Email:
ben.oleary@icr.ac.uk
Start date:
March 9, 2022
Completion date:
April 2026
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05644457
