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Recruiting

NCT Number: NCT05117723

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location status: Recruiting

Location contact

Adrian Fox

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging

Exclusion criteria

  • Patients who formally decline enrolment into the study

Treatment and study plan

Primary outcomes

  1. The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention.

    Time frame: From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years

  2. 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.

    Time frame: From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Lynn Chong

CONTACT

[email protected]

+61 3 9231 2074

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital Melbourne

Other

Collaborators

  • Epworth Healthcare

Registry information

Acronym: MAPS

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Nov 11, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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