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

NCT05574738 | Recruiting

• 1 other identifier: MI84_ECMC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Observational OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically or cytologically confirmed malignant disease (solid tumour) or a diagnosis of malignant disease made using recognised clinical criteria.
• 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.
• Written informed consent.
• Age ≥18 years.
• Able to comply with study protocol.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Eileen Soulis: lead

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Neoplasms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jeff Evans, Prof

  Cancer Research UK, Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Soulis

CONTACT

eileen.soulis@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 12, 2022
• Study Start: June 28, 2011
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

GB (1)