Biomarkers for Cancer Treatment

Characterising Circulating Biomarker Signatures From Diverse Cancer Treatment Modalities - A Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07803289

Enrollment

Registered

2026-09-03

Start date

2026-05-01

Completion date

2028-04-30

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker Discovery and Validation, Cancer

Keywords

miRNA, proteomics, blood biomarkers, cancer treatment, toxicity

Brief summary

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).

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Blood results	Baseline visit	Identifying and validating changes in miRNA expression

Secondary

Measure	Time frame	Description
Blood results	Baseline visit	Identifying and validating changes in protein biomarker profiles

Countries

United Kingdom

Contacts

CONTACTHardip Sandhu, MBA, BSc, MSc, PhD

ab1682@coventry.ac.uk+442477 659305

Outcome results