Borderline Resectable or Resectable or Advanced Pancreati... | NCT03266757

Studies
Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma

NCT03266757

Sponsor

Hellenic Society of Medical Oncology

Status

Completed

Last Update Posted

Apr 5, 2019Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Pancreatic Adenocarcinoma

Interventions

Not provided

Countries

Not provided

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2016Actual

Primary Completion Date

Feb 11, 2017Actual

Completion Date

Feb 11, 2018Actual

First Submitted Date

Jul 18, 2017

First Submission Date that Met QC Criteria

Aug 29, 2017

First Posted Date

Aug 30, 2017Actual

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

Apr 4, 2019

Last Update Posted Date

Apr 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma.

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

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

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical practice-treatments		2 years

Secondary Outcomes

Measure	Description	Time Frame
progression Free Survival		2 years
Overall Survival		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients Age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor
Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or advanced)
Patients that are alive and under treatment or follow up
Signed informed consent (ICF)

Exclusion Criteria:

Presence of other primary tumors
Pancreatic adenocarcinoma due to metastasis from other primary tumor(s)
Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma
Patients who refuse to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Public and Private Hospital Institutions

Sampling Method

Probability Sample