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2021-08-26
2031-07
2031-07
1000
NCT05117723
St Vincent's Hospital Melbourne
St Vincent's Hospital Melbourne
OBSERVATIONAL
Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer
Pancreatic cancer is the 5th leading cause of cancer death in Australia. Surgery remains the most effective treatment for early pancreatic cancer and currently the only potential for cure. Unfortunately, many patients present with advanced disease and are not suitable for surgery. Therefore, it is vital to detect these cancers early. In the absence of significant data from prospective studies, all of the guidelines are based on a critical review of available data and consensus of experts. The primary aim is to delineate the progression of IPMN to pancreatic malignancy as confirmed by surgical pathology, radiology and biochemical diagnosis. The secondary aims are (i) To outline the management of IPMNs for those who have progressed straight to surgery or surveillance by endoscopic ultrasound (EUS) (ii)To validate the International consensus guidelines for management of IPMN - Fukuoka consensus guidelines and tertiary aim to identify potential risk factors, if any that increase risk of malignancy within the IPMNs.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-10-21 | N/A | 2024-04-16 |
2021-11-02 | N/A | 2024-04-18 |
2021-11-11 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention. | From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years | |
| Risk stratification for patients with IPMN into those that require more intensive screening and possibly intervention versus those that are unlikely to progress to malignancy. | From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Lynn Chong Phone Number: +61 3 9231 2074 Email: lynn.chong@svha.org.au |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
