Condition category
Digestive System
Date applied
03/06/2010
Date assigned
10/06/2010
Last edited
10/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.unige.ch

Contact information

Type

Scientific

Primary contact

Prof Jean Louis Frossard

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Use of proteomics to differentiate between benign and potentially malignant pancreatic cystic neoplasms: a pilot study

Acronym

Study hypothesis

We 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

Ethic Committee of Hirslanden Clinic (Surgery Section), Bern approved in March 2009

Study design

Prospective cohort proteomic analysis study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Pancreatic disease

Intervention

Prospective 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/06/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with pancreatic cystic neoplasms as demonstrated by CT scan planned for open surgery
2. Each patient gave his/her informed consent before surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Age < 18 years old
2. Pregnant women

Recruitment start date

01/06/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Service of Gastroenterology
Geneva
1211
Switzerland

Sponsor information

Organisation

Geneva University Hospital (Switzerland)

Sponsor details

Rue Micheli Du Crest
Genève
1211
Switzerland
+41 (0)22 3729346
jean-louis.frossard@hcuge.ch

Sponsor type

Hospital/treatment centre

Website

http://www.hepatogastro.ch

Funders

Funder type

Hospital/treatment centre

Funder name

Geneva University Hospital (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes