NCT02646462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

June 5, 2015

Last Update Submit

January 6, 2016

Conditions

Pancreatic Cancer

Keywords

pancreas adenocarcinoma, lymph node metastases

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Number of N1 patients

    12 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Michael B Mortensen, MD, PhD,

CONTACT

45 6541 1857michael.bau.mortensen@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, MD, PhD, DMSci

Study Record Dates

First Submitted

June 5, 2015

First Posted

January 5, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

January 7, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)