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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03131076
Other study ID # IPMN Quality of life
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 7, 2017
Last updated April 26, 2017
Start date May 1, 2017
Est. completion date December 31, 2019

Study information

Verified date April 2017
Source Helsinki University Central Hospital
Contact Heini Nieminen
Phone 0035894711
Email heini.nieminen@hus.fi
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Over 500 patients were participating in the IPMN follow up between september 2014 and august 2016 at the Helsinki University Hospital. In this study we are going to determine the effects of the IPMN surveillance on the quality of life and anxiety levels of the patients.


Description:

Intraductal papillary mucinous neoplasm (IPMN) is a cystic neoplasm of the pancreas. The incidence of the tumors has increased during the last years. Some of the IPMN-tumors develop over time increasing dysplasia and at the end IPMN associated carcinoma. All IPMN-patients are kept under surveillance because of the cancer risk. This follow up can last decades and includes MRI and blood samples every 6 to 12 months. This is very expensive and the effects on the patients quality of life have not been studied before to our knowledge.

This study determines the effects of the surveillance on the patients quality of life and anxiety levels. The study will be conducted by 15D- quality of life -questionnaire and state-trait anxiety inventory (STAI) -questionaire. Both will be send to the patients before a IPMN follow up MRI and 3 months later. It is anticipated that the anxiety and the effect on the quality of life would be the highest right before the MRI and would normalize a few months after the MRI.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2019
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- all patients under IPMN surveillance

Exclusion Criteria:

- no exclusion criteria, all patients under IPMN surveillance are included

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
IPMN follow up
Follow up with MRI and laboratory blood tests

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the quality of life and anxiety 15D quality of life and STAI -questionnaire Before and 3 months after IPMN follow up MRI
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