NCT05155878

Brief Summary

The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
166mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress26%
Sep 2021Jan 2040

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

13.3 years

First QC Date

November 30, 2021

Last Update Submit

December 13, 2021

Conditions

Pancreas CancerPancreas NeoplasmPancreas CystPancreatic FistulaPancreas DiseaseBile Duct CancerPeriampullary CancerSurgerySurgery--Complications

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

    10 years

Secondary Outcomes (2)

  • Complications

    10 years

  • Radical resection

    10 years

Eligibility Criteria

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

Patients that have been recommended or already undergone surgery for a cyst or tumor in the pancreas or periampullary region

You may qualify if:

  • Recommended surgery for tumor or cyst in the pancreas or periampullary region
  • Information avalible in electronic journal files
  • Informed consent (or deceased for retrospective part of the study)

You may not qualify if:

  • No informed consent (and still alive at study initiation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Clinic at Umeå University Hospital

Umeå, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic CystPancreatic FistulaPancreatic DiseasesBile Duct Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System DiseasesCystsDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Study Officials

  • Oskar Franklin, MD/PhD

    Umeå University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar Franklin, MD/PhD

CONTACT

+4690785000oskar.franklin@umu.se

Asif Halimi, MD

CONTACT

+4690785000asif.halimi@regionvasterbotten.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 14, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2040

Last Updated

January 5, 2022

Record last verified: 2021-12

Locations

SE(1)