ISRCTN ISRCTN10626053
DOI https://doi.org/10.1186/ISRCTN10626053
Protocol serial number 001
Sponsor Geneva University Hospital (Switzerland)
Funder Geneva University Hospital (Switzerland)
Submission date
03/06/2010
Registration date
10/06/2010
Last edited
10/06/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jean Louis Frossard
Scientific

Service of Gastroenterology
Dept of Internal Medicine
Rue Micheli du Crest
Geneva
1211
Switzerland

Study information

Primary study designObservational
Study designProspective cohort proteomic analysis study
Secondary study designCohort study
Study type Participant information sheet
Scientific titleUse of proteomics to differentiate between benign and potentially malignant pancreatic cystic neoplasms: a pilot study
Study objectivesWe postulate that a proteomic analysis of pancreatic cystic fluid from patients having a pancreatic cystic neoplasms would be more performant than any other technique to discriminate between benign and malignant lesions.
Ethics approval(s)Ethic Committee of Hirslanden Clinic (Surgery Section), Bern approved in March 2009
Health condition(s) or problem(s) studiedPancreatic disease
InterventionProspective collection of pancreatic cystic fluid in patients undergoing open pancreatic surgery aimed at removing the cystic neoplams. Cystic fluid samples collected by direct puncture and submitted to proteomic analysis.
Intervention typeOther
Primary outcome measure(s)

To help find specific protein markers to better differentiate between benign and potentially malignant pancreatic cystic neoplams

Key secondary outcome measure(s)

To correlate results of the proteomic analysis to pancreatic histologic staining of surgical samples

Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration10
Key inclusion criteria1. Patients with pancreatic cystic neoplasms as demonstrated by CT scan planned for open surgery
2. Each patient gave his/her informed consent before surgery
Key exclusion criteria1. Age < 18 years old
2. Pregnant women
Date of first enrolment01/06/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Service of Gastroenterology
Geneva
1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes