Biomarkers for Cancer Treatment

September 1, 2026 updated by: University Hospitals Coventry and Warwickshire NHS Trust

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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospitals Coventry & Warwickshire NHS Trust
        • Principal Investigator:
          • Raj Shrimali
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients on treatment for cancer at UHCW NHS Trust

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients treated with RT
Patients treated with curative-intent RT/chemo-RT for lung or oesophageal cancer
Patients treated with SACT
Patients treated with IO-based complex SACT for any malignant solid tumour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood results
Time Frame: Baseline visit
Identifying and validating changes in miRNA expression
Baseline visit
Blood results
Time Frame: 12 week follow-up visit
Identifying and validating changes in miRNA expression
12 week follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood results
Time Frame: Baseline visit
Identifying and validating changes in protein biomarker profiles
Baseline visit
Blood results
Time Frame: 12 week follow-up visit
Identifying and validating changes in protein biomarker profiles
12 week follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Collaborators

Coventry University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATB 25-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe