Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNHS Lothian

About this trial

Patients with signs of radiation induced lung inflammation, who are referred for a clinical bronchoscopy for investigation, will have a sample sent for single cell sequencing. This is a novel technique which allows for identification of which cells are present and what they are doing. This hopes to better understand radiation pneumonitis, a dose-limiting toxicity in cancer treatment which can be highly morbid and even fatal.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years

Patient has received thoracic radiotherapy and has clinical or radiological features in fitting with a diagnosis of Radiation Pneumonitis (onset one to four months post-RT with breathlessness, especially exertional, cough, chest discomfort, which is persistent over weeks, a chest x-ray [CXR] may demonstrate patchy or widespread opacification although can be normal.)

Must be ambulant, oxygen independent with SpO2 >92% on air and haemodynamically stable to be considered safe for a bronchoscopy.

Willing to undergo and likely able to tolerate bronchoscopy, ie. Can lie flat without compromising ventilation, and able to consent to the ELFMAN Protocol and SPITFIRE trial.

Disqualifiers

Contraindication to bronchoscopy, ie. Previously not tolerated, unable to lie flat, Sp02 <92% on air

Patient requires admission or oxygen dependant

Test positive for Covid-19 within the preceding six weeks to enrolment

Trial population

Patients meeting the above eligibility criteria who demonstrate clinical/radiological diagnosis of radiation pneumonitis

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Single Cell Sequencing

    Diagnostic test

    Sequencing of all viable single cells present in deep bronchial brushings using transcriptomics to identify what cells are present and what they are doing.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Bronchoscopy under ELFMAN1 intervention

Trial outcomes

Primary outcomes

1

Successful creation of dataset

If deep bronchial brushings generates sufficient viable cells for processing via single-cell sequencing this will generate a dataset of cellular activity for each of these five patients. The only way to know if this technique - ie. the use of deep bronchial brushings combined with single-cell sequencing, is to run the test on the samples and therefore successful generation of the dataset is proof of feasibility of the method. There may be further use for this dataset (ie. secondary outcome below) but primarily this process will prove feasibility simply by generating data. This is not a health outcome, simply demonstration of a viable sample using a novel combination of sampling and laboratory test.

Time frame
within a month of sample collection, a year to recruit five patients

Secondary outcomes

1

Signals in pneumonitis

Comparison with normal lung dataset (publicly available) to potentially identify radiation pneumonitis signals that may be targetable via drug therapy or worth expanding to a larger trial to explore.

Time frame
3-6 months

Other outcomes

Sponsors and contacts

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