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

NCT06557343 | Recruiting

• 1 other identifier: 339413
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Radiation Pneumonitis

Keywords

radiation pneumonitis; cancer; single cell sequencing

Outcome Measures

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.

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

Secondary Outcomes (1)

• Signals in pneumonitis

  3-6 months

Study Arms (1)

Bronchoscopy under ELFMAN

Clinical bronchoscopy performed under ELMAN study

Diagnostic Test: Single Cell Sequencing

Interventions

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.

Bronchoscopy under ELFMAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (3)

Centre for Information Research, University of Edinburgh

Edinburgh, EH16 4UU, United Kingdom

NOT YET RECRUITING

Henderson Lab

Edinburgh, EH16 4UU, United Kingdom

NOT YET RECRUITING

Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoscopy sample (deep bronchial brushing) producing cellular fluid sample for processing

MeSH Terms

Conditions

Radiation Pneumonitis; Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: August 16, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)