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NCT Number: NCT07803289

Biomarkers for Cancer Treatment

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood results

    Time frame: Baseline visit

    Identifying and validating changes in miRNA expression

  2. Blood results

    Time frame: 12 week follow-up visit

    Identifying and validating changes in miRNA expression

Secondary outcomes

  1. Blood results

    Time frame: Baseline visit

    Identifying and validating changes in protein biomarker profiles

  2. Blood results

    Time frame: 12 week follow-up visit

    Identifying and validating changes in protein biomarker profiles

Study contacts

Contact information is provided by the study sponsor or research team.

Hardip Sandhu, MBA, BSc, MSc, PhD

CONTACT

[email protected]

+442477 659305

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Collaborators

  • Coventry University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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