Clinical trial NCT05574738: A Study to Explore Biomarkers in Samples of Blood, Urine, Stools, Hair Follicles and Saliva From Patients With Cancer
Official title: An Exploratory Biomarker Analysis in Blood, Urine, Stools, Hair Follicles and Saliva of Patients With Malignant Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Cancer Research UK, Glasgow
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
timeFrame: Before, during and immediately after therapeutic interventions.
measure: Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
timeFrame: Before, during and immediately after therapeutic interventions.
measure: Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
timeFrame: Before therapeutic interventions.
measure: Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
timeFrame: During therapeutic interventions
measure: Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
timeFrame: Immediately after therapeutic interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
Study officials:
affiliation: Cancer Research UK, Glasgow
name: Jeff Evans, Prof
role: PRINCIPAL_INVESTIGATOR
References: