Clinical trial · Observational
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
NCT06557343CI-TRIAL-00100541SPITFIRErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Pneumonitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Cell Sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bronchoscopy under ELFMAN
- description
- Clinical bronchoscopy performed under ELMAN study
- interventionNames
- Diagnostic Test: Single Cell Sequencing
Primary outcomes (1)
- measure
- Successful creation of dataset
- timeFrame
- within a month of sample collection, a year to recruit five patients
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.