NCT02675738

Brief Summary

Prospective, observational, cohort study to evaluate the reliability of preoperative work-up of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral center. A comparison between the preoperative diagnostic suspicion and the final pathologic report will be done.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

January 6, 2016

Last Update Submit

September 21, 2019

Conditions

Pancreatic Cystic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of cases with confirmed preoperative diagnosis

    Through study completion, on average 18 months

Interventions

good clinical practiceOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from pancreatic cystic neoplasms candidate to surgery

You may qualify if:

  • diagnosis of pancreatic cystic neoplasms
  • indication to surgery

You may not qualify if:

  • pregnancy, breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Verona Hospital Trust

Verona, Italy

RECRUITING

Central Study Contacts

Giulia De Marchi, MD

CONTACT

+390458124055giuli.dema@yahoo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 6, 2016

First Posted

February 5, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Study Completion

January 1, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

IT(1)