A Study to Explore Biomarkers in Samples of Blood, Urine, Stools, Hair Follicles and Saliva From Patients With Cancer

An Exploratory Biomarker Analysis in Blood, Urine, Stools, Hair Follicles and Saliva of Patients With Malignant Disease

The goal of this observational study is to learn about biomarkers in patients with certain types of malignant solid tumours (cancer). The main intentions are to analyse changes in biomarkers before and after treatment, determine their relationship to how a tumour responds to treatment, and potentially identify new biomarkers or genetic markers to diagnose or predict disease.

Participants will be asked to provide additional samples of blood, urine, stools, hair follicles or saliva (depending on which type of cancer they have).

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Observational

Detailed Description

This is a study in patients with confirmed malignant disease (solid tumour) due to start anti-cancer therapy/radiotherapy or attending for clinical assessment. Patients will be asked to give additional blood, hair, urine or saliva samples for research compared to standard treatment in this proposal. Blood (25 mL) will be taken, once, prior to starting therapy (or at routine assessment). Further samples of 25 mL of venous blood will be taken at each subsequent visit for chemotherapy in patients who undergo chemotherapy treatment, and at fixed timepoints for those undergoing treatment with non-chemotherapy regimens.

These timepoints will coincide with routine hospital visits for disease assessment purposes for these patients and no additional visits will be required. Similarly, a 20 mL sample of urine will be collected at the above timepoints from patients with urological cancers. A 2 mL sample of saliva will be collected at the above timepoints from patients with head and neck cancers. Where possible 25 mL of venous blood will also be collected at each subsequent follow-up visit after completion of chemotherapy (other systemic therapies, or radiation therapy) until there is documented disease progression. Patient treatment, supportive care and disease assessment will be unaffected by participation in this study. Collected samples will be analysed for biomarkers (proteins or DNA from tumour cells sometimes detected in a sample of blood or urine) at the Translational Pharmacology Lab, University of Glasgow. These biomarker results will be compared with patient outcome (objective response and overall survival) with the aim of developing biomarkers that might help us to better select the type of chemotherapy regimen given to individual patients. For patients with breast cancer who will be treated in the neo-adjuvant setting, they will be asked to provide 3 stool samples (prior to treatment, halfway through treatment and at the end of treatment) to study changes to gut microbiota.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Eileen Soulis; Email: eileen.soulis@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • Beatson West of Scotland Cancer Centre
    • Contact: Jeff Evans, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant disease identified at clinical assessment at outpatient clinics or wards, either at presentation or when they are about to undergo anti-cancer therapy.

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed malignant disease (solid tumour) or a diagnosis of malignant disease made using recognised clinical criteria.
2. Patients who are attending for clinical assessments at presentation; during a routine hospital visit for anti-cancer therapy, radiotherapy, surgery, or for whom no immediate specific therapy is planned; or at a follow-up hospital visit.
3. Written informed consent.
4. Age ≥18 years.
5. Able to comply with study protocol.

Exclusion Criteria:

(1) Any evidence of any medical or psychiatric disorders that would, in the opinion of the investigator, be a contra indication to venesection, urine, stool or saliva collection.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours	to analyse changes in the blood proteome, nucleic acids, faecal microbiome and in novel blood or urine or faecal or hair follicle or saliva biomarkers, during anti-cancer treatment in patients with malignant disease.	Before, during and immediately after therapeutic interventions.
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours	to determine if baseline values of these markers, and/or changes during anti-cancer treatment, correlate with tumour response and / or treatment-related adverse events.	Before, during and immediately after therapeutic interventions.
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours	Novel prognostic, predictive and pharmacodynamic markers in blood (or urine or stool or hair follicles or saliva) of patients with early or advanced disease baseline: pre-intervention	Before therapeutic interventions.
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours	Novel prognostic, predictive and pharmacodynamic markers in blood (or urine or stool or hair follicles or saliva) of patients with early or advanced disease baseline: during therapeutic interventions	During therapeutic interventions
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours	Novel prognostic, predictive and pharmacodynamic markers in blood (or urine or stool or hair follicles or saliva) of patients with early or advanced disease baseline: immediately after therapeutic interventions	Immediately after therapeutic interventions

Collaborators and Investigators

• Sponsor: Eileen Soulis
• Investigators: Principal Investigator: Jeff Evans, Prof, Cancer Research UK, Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2011
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MI84_ECMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No