CancerNCT05574738
A Study to Explore Biomarkers in Samples of Blood, Urine, Stools, Hair Follicles and Saliva From Patients With Cancer
An observational study of Cancer, run by Eileen Soulis at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Observational
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2011to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Eileen Soulis contact
United Kingdom1 site, 1 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Jeff Evans, Prof
About this study
Official title: 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).
Read the 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.
- Conditions
- Cancer
- Being tested
- Observational
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately after therapeutic interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start28 Jun 2011
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eileen Soulis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eileen Soulis, Cancer Research UK, Glasgow
- Investigators
- Jeff Evans, Prof, Principal investigator, Cancer Research UK, Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574738
- Sponsor's protocol ID
- MI84_ECMC
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Biomarker Analysis in Blood, Urine, Stools, Hair Follicles and Saliva of Patients With Malignant Disease
- ClinicalTrials.gov ID
- NCT05574738
- Acronym / sponsor ID
- MI84_ECMC
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eileen SoulisUniversity, hospital or other
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational | Other | – |
Primary outcome
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
Time frame: Before, during and immediately after therapeutic interventions.
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.
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
Time frame: Before, during and immediately after therapeutic interventions.
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.
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
Time frame: Before therapeutic interventions.
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
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
Time frame: During therapeutic interventions
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
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours
Time frame: Immediately after therapeutic interventions
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Soulis contact
Jeff Evans, Prof principal investigator
Cancer Research UK, Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Eileen Soulis at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen Soulis (eileen.soulis@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect blood and/or, where appropriate, urine, hair, stool or saliva samples from patients with solid tumours (time frame: Before, during and immediately after therapeutic interventions.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.