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).
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Hardip Sandhu, MBA, BSc, MSc, PhD
- Telefonnummer: +442477 659305
- E-mail: ab1682@coventry.ac.uk
Studiesteder
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Coventry, Det Forenede Kongerige, CV2 2DX
- Rekruttering
- University Hospitals Coventry & Warwickshire NHS Trust
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Ledende efterforsker:
- Raj Shrimali
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Kontakt:
- Raj Shrimali, MBBS, FRCR, FRCP, PhD
- Telefonnummer: +44 2476 966197
- E-mail: Raj.Shrimali@uhcw.nhs.uk
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Kontakt:
- Sean James
- Telefonnummer: +442476 965248
- E-mail: sean.james@uhcw.nhs.uk
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ATB 25-18
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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