Prognostic Factors in Periampullary Tumors and Cysts | NCT05155878

Studies
Prognostic Factors in Periampullary Tumors and Cysts

NCT05155878

Sponsor

Umeå University

Status

Recruiting

Last Update Posted

Jan 5, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pancreas Cancer
Pancreas Neoplasm
Pancreas Cyst
Pancreatic Fistula
Pancreas Disease
Bile Duct Cancer
Periampullary Cancer
Surgery
Surgery--Complications

Interventions

Not provided

Countries

Sweden

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jan 1, 2035Estimated

Completion Date

Jan 1, 2040Estimated

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Nov 30, 2021

First Posted Date

Dec 14, 2021Actual

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

Dec 13, 2021

Last Update Posted Date

Jan 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

Detailed Description

From november 2021 an onward, study participants will be prospectively enrolled within the observational study. Before that, study participants are retrospectively enrolled. The study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival	10 years

Secondary Outcomes

Measure	Description	Time Frame
Complications	Clavien-Dindo, Specific procedure related outcomes	10 years
Radical resection	Rates of R0 vs R1/2 resections	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

No informed consent (and still alive at study initiation)

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oskar Franklin, MD/PhD	Contact	+4690785000		oskar.franklin@umu.se
Asif Halimi, MD	Contact	+4690785000		asif.halimi@regionvasterbotten.se

Overall Officials

Name	Affiliation	Role
Oskar Franklin, MD/PhD	University Hospital, Umeå	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgical Clinic at Umeå University Hospital	Recruiting	Umeå		90185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D010181	Pancreatic Cyst
D010185	Pancreatic Fistula
D010182	Pancreatic Diseases
D001650	Bile Duct Neoplasms

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