NCT05134961

Brief Summary

The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1999

Completed
21.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

21.7 years

First QC Date

November 16, 2021

Last Update Submit

November 16, 2021

Conditions

Duodenal Cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year survival

    Cumulative survival after three years

    Three years

Secondary Outcomes (1)

  • Duodenal cancer recurrence

    5 years

Study Arms (1)

Patients undergoing resection of primary duodenal cancer

Tumors comprised histologically confirmed adenocarcinomas in the duodenum excluding adenocarcinoma of the ampulla of Vater and adenocarcinomas with gastric and pancreato-biliary morphology and immunohistochemistry.

Procedure: Pancreaduodenectomy and possible adjuvant therapy

Interventions

Pancreaduodenectomy and possible adjuvant therapyPROCEDURE

Adjuvant therapy was generally offered to patients with T4 or lymph node positive disease. As no national Danish guidelines exist, patients were treated based on the oncologists' preference.

Patients undergoing resection of primary duodenal cancer

Eligibility Criteria

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

Patients subjected to resection of primary duodenal adenocarcinoma

You may qualify if:

  • Patients subjected to resection of primary duodenal adenocarcinoma

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristian Schaumburg Kiim

Copenhagen NV, Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Duodenal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesDuodenal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d., DMSc

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 26, 2021

Study Start

January 1, 1999

Primary Completion

August 31, 2020

Study Completion

September 30, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)