Biomarkers for Cancer Treatment
Characterising Circulating Biomarker Signatures From Diverse Cancer Treatment Modalities - A Pilot Study
Circulating biomarkers, such as miRNAs and proteomics, undergo identifiable and measurable changes during and following treatment for cancer, compared to pre-treatment baseline. Some of these changes may be associated either with known treatment parameters or predictive for cardiac or lung toxicity.
The aim is to identify and validate changes following treatment for cancer, compared to pre-treatment baseline, as well as differential miRNA expression in two-group comparisons (patients receiving radical RT/chemoRT for thoracic cancers versus IO-based complex SACT).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
To identify and validate changes in miRNA pre- and post- radical RT/chemo-RT (cohort 1) and pre- and post- IO-based complex SACT (cohort 2) and elucidate links between dysregulated miRNAs and clinical evaluations.
To identify and validate changes in protein biomarker profile (1,034 protein targets) pre- and post- radical RT/chemo-RT (cohort 1) and pre- and post- IO-based complex SACT (cohort 2) and to elucidate links between changes in proteins relevant to immune and inflammatory pathways and clinical evaluations.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Hardip Sandhu, MBA, BSc, MSc, PhD
- Telefonnummer: +442477 659305
- E-post: ab1682@coventry.ac.uk
Studieorter
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Coventry, Storbritannien, CV2 2DX
- Rekrytering
- University Hospitals Coventry & Warwickshire NHS Trust
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Huvudutredare:
- Raj Shrimali
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Kontakt:
- Raj Shrimali, MBBS, FRCR, FRCP, PhD
- Telefonnummer: +44 2476 966197
- E-post: Raj.Shrimali@uhcw.nhs.uk
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Kontakt:
- Sean James
- Telefonnummer: +442476 965248
- E-post: sean.james@uhcw.nhs.uk
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Adult patients (Age >18 years)
- Histologically/Cytological confirmed solid tumour
- Treated with radical RT or concurrent chemo-RT (Cohort 1) OR
- Treated with chemo-IO or IO-IO combination (Cohort 2)
- First-line treatment
- Able to provide informed consent
- Willing to comply with study procedures
Exclusion Criteria:
- Contraindication for RT or chemotherapy (Cohort 1) OR
- Contraindication for chemotherapy or IO (Cohort 2)
- Use of chemotherapy or immunotherapy in the last 5 years. (Cohort 1) OR
- Use of radical RT or chemo-RT within the thorax in the last 5 years. (Cohort 2)
- Beyond first-line treatment (second line onwards)
- Has more than 1 active cancer requiring treatment
- Recent participation in an interventional study
- Pregnant or breastfeeding women
- On long term cytotoxics or immune-modulators for rheumatoid arthritis or connective tissue disorders or auto-immune disorders
- Poor life expectancy, likely less than 6 months
- Patients not likely to comply with treatment or the study
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Patients treated with RT
Patients treated with curative-intent RT/chemo-RT for lung or oesophageal cancer
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Patients treated with SACT
Patients treated with IO-based complex SACT for any malignant solid tumour
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood results
Tidsram: Baseline visit
|
Identifying and validating changes in miRNA expression
|
Baseline visit
|
|
Blood results
Tidsram: 12 week follow-up visit
|
Identifying and validating changes in miRNA expression
|
12 week follow-up visit
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood results
Tidsram: Baseline visit
|
Identifying and validating changes in protein biomarker profiles
|
Baseline visit
|
|
Blood results
Tidsram: 12 week follow-up visit
|
Identifying and validating changes in protein biomarker profiles
|
12 week follow-up visit
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ATB 25-18
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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