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Trial Title:
A Study to Explore Biomarkers in Samples of Blood, Urine, Stools, Hair Follicles and Saliva From Patients With Cancer
NCT ID:
NCT05574738
Condition:
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Jeff Evans, Prof
Start date:
June 28, 2011
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Eileen Soulis
Agency class:
Other
Source:
Cancer Research UK, Glasgow
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05574738
