Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer

NCT05117723 | Recruiting

• 1 other identifier: 76739
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IPMN, Pancreatic; IPMN

Keywords

pancreatic cyst

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with IPMN will be identified from consultations at each hospital site with surgical and medical specialists with an interest in pancreatic conditions. This will occur via consultations conducted in public clinic settings and from private consultations and multi-disciplinary meetings.

You may qualify if:

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

You may not qualify if:

• Patients who formally decline enrolment into the study

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead
• Epworth Healthcare: collaborator

Study Sites (1)

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Study Officials

• Adrian Fox

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn Chong

CONTACT

+61 3 9231 2074; lynn.chong@svha.org.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 11, 2021
• Study Start: August 26, 2021
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

AU (1)