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).
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Hardip Sandhu, MBA, BSc, MSc, PhD
- Telefonnummer: +442477 659305
- E-post: ab1682@coventry.ac.uk
Studiesteder
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Coventry, Storbritannia, CV2 2DX
- Rekruttering
- University Hospitals Coventry & Warwickshire NHS Trust
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Hovedetterforsker:
- Raj Shrimali
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Ta kontakt med:
- Raj Shrimali, MBBS, FRCR, FRCP, PhD
- Telefonnummer: +44 2476 966197
- E-post: Raj.Shrimali@uhcw.nhs.uk
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Ta kontakt med:
- Sean James
- Telefonnummer: +442476 965248
- E-post: sean.james@uhcw.nhs.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Blood results
Tidsramme: Baseline visit
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Identifying and validating changes in miRNA expression
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Baseline visit
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Blood results
Tidsramme: 12 week follow-up visit
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Identifying and validating changes in miRNA expression
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12 week follow-up visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood results
Tidsramme: Baseline visit
|
Identifying and validating changes in protein biomarker profiles
|
Baseline visit
|
|
Blood results
Tidsramme: 12 week follow-up visit
|
Identifying and validating changes in protein biomarker profiles
|
12 week follow-up visit
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
- ATB 25-18
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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