Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT06357416
Eligibility Criteria:
Patients are eligible to be included in the research study if they are eligible to access the Man Van mobile outreach clinic, which is a novel clinical service delivered by The Royal Marsden Hospital NHS Foundation Trust. The inclusion and exclusion criteria have been designed to be as broad as possible, in order to include data from as many patients using the Man Van clinical service as possible.
As the primary purpose of the Man Van mobile outreach clinic is to screen for prostate, testicular, penile and other cancers that affect men, only men are eligible to be reviewed in the mobile outreach clinic hence only males will be recruited into this study.
Inclusion criteria for the Main Study
1. Participating in the linked Man Van mobile outreach clinic
2. Age ≥45 years
3. Male
(The initial pilot study had a age criteria of ≥18 years, but this was amended).
MV-POCT
Inclusion Criteria: Any patient having a PSA and/or an HbA1c test as part of a Man Van work up, or via the our rapid diagnostics clinic.
MV-QualQ
Inclusion Criteria: Any patient attending the Man Van for an assessment.
MV-Eco
Inclusion Criteria: Any patient attending the Man Van for an assessment.
MV-PRS
Inclusion Criteria: Any patient attending the Man Van for an assessment and able to provide saliva samples.
MV-DNA
Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to provide blood/saliva samples.
MV MV-UctDNA
Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to provide urine samples.
MV-SSI
Inclusion criteria:
* Aged \> 18 and over (on date of invitation to participate)
* Works for healthcare organisation, other stakeholder or professional or potential man van patient who was not seen or relative of a Man Van patient/potential patient
Exclusion criteria:
* Man van patient who has attended appointment
MV-TPP
Inclusion criteria:
Healthcare Professionals
* Aged \> 18 and over (on date of invitation to participate)
* Speaks English
* Works within the UK
* Profession: GPs, Practice Staff (Nurses, Physician Assistants and Associates
* Healthcare assistants)
* Experienced in adopting new tests and guidelines into practice.
* Experienced in detecting, managing, and referring symptoms and asymptomatic patients with symptoms of prostate, pancreatic, GI cancer and/or are at an increased risk of developing these cancers.
Patients
* Aged \> 18 and over (on date of invitation to participate)
* Speaks English
* Lives in the UK
* Patients with direct and in-direct experience with prostate, pancreatic, GI cancers.
* Patients at an increased risk of developing prostate, pancreatic, GI cancer in accordance with known risk factors, which includes age, smoking, being overweight or obese, family history and genetic factors, pancreatitis, and diabetes.
Other key stakeholders/professionals
• Aged \> 18 and over (on date of invitation to participate)
• Speak English
* Works within the UK
* Professions: medical devices and biomedical researchers, scientists, representatives for major regulatory and funding bodies
* Knowledgeable of Early Detection initiatives (tests, outreach programes)
Exclusion criteria:
GPs
• Individuals who are unwilling to take part in the study.
* Individuals with no experience in adopting new cancer tests and guidelines into practice.
* Individuals with no experience in in detecting, managing, and referring patients with symptoms of cancer and/or are at an increased risk of developing prostate, pancreatic, GI cancer.
* Individuals who do not adequately understand verbal explanations or written information in English.
Patients • Individuals who are unwilling to take part in the study.
• Individuals who do not adequately understand verbal explanations or written information in English.
• Unable to provide written and verbal consent.
• No direct or indirect lived experience with prostate, pancreatic, GI cancers.
Non-clinical key stakeholders/professionals • Individuals who are unwilling to take part in the study • Individuals who are not familiar with cancer biomarkers and medical tests • Individuals with no knowledge of early detection
• Individuals who do not adequately understand verbal explanations or written information in English
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06357416
Study Brief:
Protocol Section:
NCT06357416