IPMNNCT03131076
Quality of Life Assessment in Patients Who Are Under Surveillance for IPMN
An observational study of IPMN and Quality of Life, run by Helsinki University Central Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IPMN, Quality of Life
- What is being tested?
- IPMN follow up
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 31 Dec 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients under IPMN follow up
Who may be able to join
- all patients under IPMN surveillance
Who cannot join
- no exclusion criteria, all patients under IPMN surveillance are included
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu
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.
Read the detailed 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.
- Conditions
- IPMN, Quality of Life
- Being tested
- IPMN follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPMN follow upDiagnostic test
Follow up with MRI and laboratory blood tests
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the quality of life and anxiety
15D quality of life and STAI -questionnaire
Measured: Before and 3 months after IPMN follow up MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IPMNStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heini Nieminen, Helsinki University Central Hospital
- Investigators
- Heini Nieminen, Principal investigator, Helsinki Universtity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131076
- Sponsor's protocol ID
- IPMN Quality of life
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared.
Publications
Nieminen H, Roine R, Ristimaki A, Lantto E, Valimaa N, Kirveskari E, Sintonen H, Haglund C, Seppanen H. Health-related quality of life and anxiety levels among patients under surveillance for intraductal papillary mucinous neoplasm. BMC Gastroenterol. 2023 Jan 16;23(1):14. doi: 10.1186/s12876-023-02639-0.
PubMed 36647007
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu
- ClinicalTrials.gov ID
- NCT03131076
- Acronym / sponsor ID
- IPMN Quality of life
- Conditions
- IPMN, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients under IPMN follow up
Key inclusion criteria (1 listed)
- all patients under IPMN surveillance
Key exclusion criteria (1 listed)
- no exclusion criteria, all patients under IPMN surveillance are included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPMN follow upFollow up with MRI and laboratory blood tests | Diagnostic test | – |
Primary outcome
Change in the quality of life and anxiety
Time frame: Before and 3 months after IPMN follow up MRI
15D quality of life and STAI -questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 36647007Nieminen H, Roine R, Ristimaki A, Lantto E, Valimaa N, Kirveskari E, Sintonen H, Haglund C, Seppanen H. Health-related quality of life and anxiety levels among patients under surveillance for intraductal papillary mucinous neoplasm. BMC Gastroenterol. 2023 Jan 16;23(1):14. doi: 10.1186/s12876-023-02639-0.
- Individual participant dataSharing planned: No. Data will not be shared.
Related trials for IPMN
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Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Pancreatic Cyst
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Real-Time AI During Pancreatoscopy for Detection of Pancreatic Neoplasia
Intraductal Papillary Mucinous Neoplasm of Pancreas, Pancreatic Neoplasms
Active, not recruitingPhase 2
The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
IPMN, IPMN, Pancreatic
Enrolling by invitationObservational study
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
IPMN, Pancreatic, Pancreas Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heini Nieminen principal investigator
Helsinki Universtity Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of IPMN and Quality of Life, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heini Nieminen (0035894711, heini.nieminen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the quality of life and anxiety (time frame: Before and 3 months after IPMN follow up MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03131076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.