Character Traits and Stress in Suspected Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02031029|
Recruitment Status : Terminated (Stopped by the sponsor due to discrepancies in the recruitment process.)
First Posted : January 9, 2014
Last Update Posted : March 31, 2017
|Condition or disease|
Men who are being referred as new urological outpatient and meet the following criteria:
- Wanted clinical examined because of elevated PSA
- Not strong family history of prostate cancer
- It is taken biopsy as part of routine investigation.
Control groups: Men being referred to urological / gastroenterological outpatient clinic, and which meet the following criteria:
- urination complaints, normal PSA, and study shows prostate size> 40cc
- Or melena and cancer suspicion in colorectum
- Age> 18 years and <75 years
Together with statistician look for patterns / covariance in replies from those who are diagnosed with prostate cancer in the questionnaires personality evaluation adapted to normal population (Neo-FFI), gender differentiated stress response questionnaire (MGRSS) and questionnaires related to resilience, relationship and quality of life index, compared with the control groups.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||51 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||A Questionnaire Study by Elevated Prostate Specific Antigen (PSA): Do Men Where Subsequent Assessment Shows Prostate Cancer, Higher Levels of Neuroticism and Stress Compared to Those Who do Not Get the Diagnosis?|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 18, 2015|
|Actual Study Completion Date :||December 18, 2015|
- MGRSS questionnaire [ Time Frame: 2 years ]The profile of the answering patterns will be compared to baseline using psychiatric and statistical evaluation.
- Testosterone [ Time Frame: 2 years ]Testosterone at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
- Cholesterol [ Time Frame: 2 years ]Cholesterol at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
- Vitamin D, Folic acid, White Blood Cells, C-reactive protein (CRP) [ Time Frame: 2 years ]Blood values at baseline and 2 years will be related to wether the patient has confirmed cancer or not.
- coffee and green tea consumption [ Time Frame: 2 years ]The consumption of coffee and green tea will be related to wether the patient has confirmed cancer or not.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031029
|Akershus University Hospital|
|Lørenskog, Norway, NO-1478|
|Stavanger University Hospital, urological department|
|Stavanger, Norway, NO-4011|
|Principal Investigator:||Gunn Iren Meling, MD PhD||Helse Stavanger HF|