Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Analiza sekwencjonowania pojedynczych komórek sygnałów popromiennego zapalenia płuc u pacjentów leczonych radioterapią z powodu raka (SPITFIRE)

4 listopada 2026 zaktualizowane przez: NHS Lothian

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Lung cancer is the third most common cancer in the UK with around 48,500 people diagnosed with the condition each year. Unfortunately, despite significant progress in treatment options and their delivery, improvements in survival remain elusive. Radiotherapy (RT) is a cornerstone of both radical and palliative treatment in non-small cell lung cancer (NSCLC). Radiation pneumonitis (RP) is the key dose-limiting constraint and a morbid, potentially even life-threatening, toxicity associated with RT to the thorax. Newer combinations of chemo-radiotherapy and adjuvant immunotherapy demonstrate improved survival but are associated with higher risk of RP.

Current management of RP is very limited consisting of supportive measures and steroids; the latter of which are often ineffective and come with their own risks. The typical triad of symptoms (exertional dyspnoea, a non-productive cough and hypoxia) can be directly fatal for some whilst for others represent a devastating and permanent decline in their lung function and quality of life. Although modest understanding of the patient and treatment related risk factors for RP development have been identified the underlying mechanisms remain poorly understood and has been challenging to investigate. A cascade of inflammatory changes with hypoxia lead to endovascular damage, cytokine release and ultimately endothelial cell death and irreversible fibrosis. Single-cell RNA sequencing (scRNA-seq) is a relatively novel technique that allows access to an understanding of this process. It can allow the identification of what genetics, cell types and functional heterogeneity are up/down-regulated in association with irradiated lung tissue in humans.

It is known that Stereotactic-Ablative Radiotherapy (SABR) is a well-tolerated highly conformal form of RT. It has been safely delivered to patients before radical surgery without significant toxicity or increase in complication rate. If a targetable mechanism behind this condition could be identified it has the potential to change the landscape of lung cancer RT management and in doing so save lives.

A literature search revealed no investigation like this has been conducted in humans. A Chinese study has been done in murine models and demonstrated several signals which, if demonstrated in humans, could be of interest. SPITFIRE proposes to obtain inflamed lung tissue from patients who have developed pneumonitis following radiation for their lung cancer to find these answers.

1.2 RATIONALE FOR STUDY Both patients who have potentially been cured of their lung cancer and those being treated to alleviate symptoms in their last months-to-years of life are diagnosed with RP. Potentially treatable disease can be refused due to an unacceptable combination of risk factors for developing RP. Hospitalisation for RP is common and yet often frustratingly unhelpful. RP is a major contributor to patient morbidity, mortality and healthcare cost. Although clearly a constant concern in lung cancer any radiation delivered through the chest (including oesophageal, breast and pulmonary metastatic RT) carries a risk of RP.

Pulmonary fibrosis treatment is starting to improve with novel agents such as Nintedanib and Pirfenidone demonstrating some promise. There is likely, though yet unproven, crossover between the molecular and genetic processes involved in these conditions. Should a better understanding of the mechanisms behind RP reveal a targetable signal, and subsequent treatment, it has the potential to completely change not only the management of this toxicity but that of thoracic malignancies.

Obtaining tissue from human lung affected by RP is a challenge. These patients are often too unstable to safely proceed with such intervention. There is, however, a population of patients who have clinical and radiological features diagnostic of the condition but maintain oxygen saturations (SpO2) adequate to proceed to bronchoscopy. Some of these patients will be referred for a bronchoscopy to exclude super-added infection. As part of this process they may be enrolled in the ELFMAN (Edinburgh Lung Fibrosis Molecular Endotyping) Study - to better characterise suspected inflammatory and fibrotic interstitial lung disease, as it may have shared molecular pathways to interstitial pneumonias including idiopathic pulmonary fibrosis (IPF). Standard bronchoscopy may not reach the effect area of lung but deep bronchial brushings obtains a good cellular yield which should be adequate for scRNA-seq whilst minimising risk to the patient. This study proposes to utilise a brushing from these patients to process using a novel laboratory technique to help identify the cellular processes that may be involved in radiation pneumonitis.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

5

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Edinburgh, Zjednoczone Królestwo, EH4 2XU
        • Rekrutacyjny
        • Edinburgh Cancer Centre
        • Kontakt:
        • Kontakt:
      • Edinburgh, Zjednoczone Królestwo, EH16 4UU
        • Jeszcze nie rekrutacja
        • Centre for Information Research, University of Edinburgh
        • Kontakt:
      • Edinburgh, Zjednoczone Królestwo, EH16 4UU

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: CASE_ONLY
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Bronchoscopy under ELFMAN

Clinical bronchoscopy performed under ELMAN study

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Successful creation of dataset
Ramy czasowe: within a month of sample collection, a year to recruit five patients

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Signals in pneumonitis
Ramy czasowe: 3-6 months

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.

3-6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

25 października 2024

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

1 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

3 czerwca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2024

Pierwszy wysłany (Rzeczywisty)

16 sierpnia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 339413

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Linked anonymized data only

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .