Influence of Gemcitabine Treatment on Immunological and S... | NCT00947102

Studies
Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer

NCT00947102

Sponsor

Blood Transfusion Centre of Slovenia

Status

Unknown status

Last Update Posted

Jan 13, 2010Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Pancreatic Tubular Adenocarcinoma

Interventions

Observation

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2010

Last Update Posted Date

Jan 13, 2010Estimated

Name	Class
University Medical Centre Ljubljana	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pancreatic tubular adenocarcinoma		Patients with pancreatic tubular adenocarcinoma	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other		Pancreatic tubular adenocarcinoma

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ECOG performance status 0-2 at the time of inclusion
Following R0 or R1 pancreatic tubular adenocarcinoma resection

Exclusion Criteria:

Pregnancy
Serious comorbidity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients after resection of pancreatic tubular adenocarcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Borut Stabuc, MD, PhD	Contact	+386 1 522 22 10		borut.stabuc@kclj.si
Lojze Smid, MD	Contact			lojze.smid.jr@mf.uni-lj.si

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana; Department for Gastroenterology	Recruiting	Ljubljana	Ljubljana	1000	Slovenia

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided