Primary Objective: Establishment of an extensive PCa biobank for blood, urine, prostate tissue, lymph node tissue, and metastatic tissue in combination with clinical data, which can be used for future PCa research.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Establishment of an extensive PCa biobank which can be used for future PCa
research.
Secondary outcome
Not applicable.
Background summary
A major drawback of the standard diagnostic tools for PCa is the detection of
small non-aggressive or non-life threatening cancers, leading to overdiagnosis
and overtreatment, as well as the detection of tumours that are too advanced to
cure. Currently, there are no blood or urine markers available for the
prognosis of PCa at the time of early disease stages apart from PSA.
Improved diagnostic and prognostic markers are required that can discriminate
men with clinically irrelevant PCa, curable PCa, or life threatening PCa. For
this purpose we want to collect various body tissues and fluids from male
patients with (the suspicion of) prostate cancer visiting the (outpatient)
clinic of the Department of Urology.
Study objective
Primary Objective:
Establishment of an extensive PCa biobank for blood, urine, prostate tissue,
lymph node tissue, and metastatic tissue in combination with clinical data,
which can be used for future PCa research.
Study design
This study is a prospective observational study.
Study burden and risks
The biobank will be composed of blood, urine, prostate tissue, lymph node
tissue, and metastatic tissue. Blood collection will preferably take place
combined with a venepuncture done as standard of care to minimise patient
burden. Urine will be collected after DRE (digital rectal examination) of the
prostate. Urine collection will be combined as much as possible with a DRE of
the prostate done as standard of care to minimise patient burden. Urine
collection will only take place in patients in whom the prostate has not been
surgically removed.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Men >= 18 years.
- Patients with (the suspicion of) prostate cancer visiting the Department of Urology for standard care.
- Mentally and physically able to participate.
- Enough knowledge of the Dutch language to understand the informed consent form.
- Written informed consent.
Exclusion criteria
- Known HIV-infection or other serious infectious disease which can be transferred by one of the biomaterials.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33818.078.11 |