Systematic Lymph Node Sampling and Analysis in Patients W... | NCT02646462

Studies
Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

NCT02646462

Sponsor

Michael Bau Mortensen

Status

Unknown status

Last Update Posted

Jan 7, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

Not provided

Countries

Denmark

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

Jan 2016

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

Jun 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jun 5, 2015

First Submission Date that Met QC Criteria

Jan 4, 2016

First Posted Date

Jan 5, 2016Estimated

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 6, 2016

Last Update Posted Date

Jan 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Bau Mortensen, professor, MD, PhD, DMSci, Odense University HospitalSponsor-Investigator

Lead Sponsor

Michael Bau MortensenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Detailed Description

Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ratio of malignant/total number of lymph nodes	Ratio between malignant and total number of lymph nodes in predefined lymph node stations	12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of N1 patients	Number of patients with malignant lymph nodes in predefined lymph node stations	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla)

Exclusion Criteria:

Patients with non-adenocarcinoma tumors of the pancreas or periampullary region

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla) referred for pancreas resection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael B Mortensen, MD, PhD,	Contact	45 6541 1857		michael.bau.mortensen@rsyd.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital	Recruiting	Odense C		5000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D008207	Lymphatic Metastasis

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided