The aim of this study is to validate the effectiveness of the Stockholm3 test in the Netherlands setting with dutch patients.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome
* Number of biopsies
Secondary outcome
Secondary outcome
* Number of biopsies with Gleason Score * 7
* Number of biopsies with Gleason Score 6
* Number of MRIs
Background summary
Prostate cancer constitutes about 15 % of new cases of cancer among men
globally.
A number of risk factors have been suggested for prostate cancer, including
diet and occupational exposure, but the only factors that are conclusively
associated with risk are age, ethnicity and family history. Given the high
prevalence of the cancer and the limited opportunities for primary prevention,
it has long been expected that a good screening test would both reduce the
mortality of prostate cancer and its general burden on health.
Study objective
The aim of this study is to validate the effectiveness of the Stockholm3 test
in the Netherlands setting with dutch patients.
Study design
Patients who are scheduled for prostate MRI and/or prostate biopsy will be
asked to donate 12 ml of blood and to answer three clinical questions. Data on
patient*s PSA value as well as result from follow-up clinical care (MRI and/or
biopsy) will be collected. Stockholm3 analysis will be conducted
retrospectively on the blood collected.
Study burden and risks
The following ethical considerations and questions have been identified:
Is there any discomfort participating in the S3VAL?
There is a potential discomfort when the blood sample is taken. However, the
blood sample will be taken by very experienced staff that are accustomed to
taking blood samples.
What to do if a high-risk patient is detected in the follow-up analysis with
Stockholm3 that was not taken care in the regular care?
S3VAL is an observational study, i.e. no decision on care will be taken based
on the Stockholm3 test. There is however a slight possibility that men with
very high risk might have been missed in regular care and that this will be
detected in the follow-up data collection. If such an event would occur, you
will be contacted by your doctor and receive the result from the Stockholm3
test as well as information on additional follow-up care.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Patients with no previous prostate cancer diagnosis who are scheduled for prostate MRI and/or prostate biopsy.
Exclusion criteria
Patiënt with previous prostate cancer in medical history,
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 | NL63852.042.17 |