- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04629079
Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging (LungExoDETECT)
Lung Cancer Detection Using Blood Exosomes and HRCT- Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Lung cancer is the leading cause of cancer deaths. Screening for early detection of cancer at an early stage reduces cancer deaths and therefore improves prognosis. The National Lung Screening Trial (NLST), for instance, showed that CT screening increases the early detection rate, and reduces mortality. However, drawbacks include over-diagnosis, false-positive results, psychological distress and cost. Therefore, lung cancer screening is not recommended or available within the NHS.
Diagnosis of lung cancer is currently based on a combination of scans and tissue biopsy. The invasive nature of current diagnostic procedures limits their application. To improve the efficacy and cost effectiveness of screening in early detection of lung cancer, additional, complementary and non-invasive methods, such as circulating biomarkers, should be evaluated. Our novel exosomal assay (taken from a blood sample) when combined with CT, may improve the current accuracy of lung cancer detection, especially that of a worse clinical prognosis. Improvement in the accuracy of detection and/or prediction of future disease by performing the combined imaging exosome test will cause a paradigm shift. Moving towards the identification of blood tests can help increase confidence about follow-up decisions and shorten the interval before biopsy.
This prospective cohort study will recruit patients referred to secondary care for the investigation of clinical symptoms or signs suspicious of lung cancer.
The study will run between 2020 and 2024 (two-year active recruitment and two-year follow up).
Participants will have a single assay of blood taken on one occasion in the lung clinic by trained staff.
Participants will have normal standard of care chest CT scans and this data will be used.
All participants will be actively followed for 3 months and then those with nodules, revealed by CT Scan, at 3 monthly intervals. Longitudinal clinical data will be collected on the investigations, diagnoses and outcomes of all study patients.
Data will be collected on date, type and results of imaging and biopsy investigations including nodule size and progression.
For those diagnosed with lung cancer, data on tumour size, stage, type and other markers) will be recorded together with treatment response and date of death, where this occurs within the study.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Carina Cruz, MRes
- Telefonnummer: 01438 284435
- E-post: carina.cruz@nhs.net
Studiesteder
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Stevenage, Storbritannia, SG1 4AB
- Rekruttering
- Borthwick Research Unit, Lister Hospital
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Ta kontakt med:
- Carina Cruz, MRes
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Over 18 years of age
- Suspected clinical diagnosis of lung cancer
- Able to provide informed consent
Exclusion Criteria:
-Synchronous other cancer types.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population.
Tidsramme: Through study completion, an average of 2 years.
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Describe the expression of hypoxia- response element (HRE) responsible protein P4HA1 utilising a hypoxia-reporting cancer exosomal assay in participants being clinically assessed for suspected lung cancer.
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Through study completion, an average of 2 years.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Describe the range of expression of precursor microRNA in exosomes derived from participants being clinically assessed for suspected lung cancer and compare the range of expression between the cancer and non-cancer participant population.
Tidsramme: Through study completion, an average of 2 years.
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Utilise exosome-based assessment of pre-microRNA processing to inform the development of a hypoxia gene signature for the early detection of lung cancer.
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Through study completion, an average of 2 years.
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Develop a combined risk score combining multi-dimensional parameters to discriminate between cancer cases and non-cancer cases.
Tidsramme: Through study completion, an average of 2 years.
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To develop a combined risk prediction model to support the early diagnosis of lung cancer.
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Through study completion, an average of 2 years.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Thida Win, MD, Lister Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 261766
Plan for individuelle deltakerdata (IPD)
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