Pancreatic Cystic NeoplasmsNCP-1NCT02675738
Reliability of the Preoperative Work-up in Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas
An observational study of Pancreatic Cystic Neoplasms, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cystic Neoplasms
- What is being tested?
- good clinical practice
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from pancreatic cystic neoplasms candidate to surgery
Who may be able to join
- diagnosis of pancreatic cystic neoplasms
- indication to surgery
Who cannot join
- pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Verona Hospital Trust
Verona
Giulia De Marchi, MD, +390458124055, giuli.dema@yahoo.it
About this study
Official title: Reliability of the Preoperative Work-up in a Prospective Series of Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas
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.
- Conditions
- Pancreatic Cystic Neoplasms
- Being tested
- good clinical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
good clinical practiceOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with confirmed preoperative diagnosis
Measured: Through study completion, on average 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cystic NeoplasmsStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Frulloni, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675738
- Sponsor's protocol ID
- NCP-1
- Acronym
- NCP-1
- Status last verified
- Sep 2019
- First submitted
- 6 Jan 2016
- Last updated
- 24 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Preoperative Work-up in a Prospective Series of Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas
- ClinicalTrials.gov ID
- NCT02675738
- Acronym / sponsor ID
- NCP-1 / NCP-1
- Conditions
- Pancreatic Cystic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Feb 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from pancreatic cystic neoplasms candidate to surgery
Key inclusion criteria (2 listed)
- diagnosis of pancreatic cystic neoplasms
- indication to surgery
Key exclusion criteria (1 listed)
- pregnancy, breastfeeding
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 |
|---|---|---|
| good clinical practice | Other | – |
Primary outcome
Number of cases with confirmed preoperative diagnosis
Time frame: Through study completion, on average 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cystic Neoplasms, run by Universita di Verona at 1 site in Italy.
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 2 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Giulia De Marchi, MD (+390458124055, giuli.dema@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases with confirmed preoperative diagnosis (time frame: Through study completion, on average 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.