ClinicalTrials.gg
RecruitingNCT05155878Updated Jan 5, 2022

Prognostic Factors in Periampullary Tumors and Cysts

An observational study in Pancreas Cancer, Pancreas Neoplasm and Pancreas Cyst, sponsored by Umeå University. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.

Sponsored by Umeå University · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Pancreatic Neoplasms with a site in Sweden — 19 open to participants now, 24 under way, 7 of them phase 3. Pancreatic Neoplasms · Sweden.

Planned enrollment
6th of 12
500 · median 496
Started
2021
with 2 others
Observational
12 of 54
6 open now
Primary completion
2035-01
later than 23 of 23 live
Registered
34th of 54
by date
Lead sponsor
2 of 54
Umeå University

Among the 54 studies in Pancreatic Neoplasms with a site in Sweden, this one is the 6th largest by planned enrollment of the 12 observational ones that give a count, is one of 3 that started in 2021, is one of 12 observational ones, reaches primary completion later than 23 of the 23 other live ones, and was the 34th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

19 of the 54 studies in Pancreatic Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:

13 more — sign in →

All 19 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 54 studies in Pancreatic Neoplasms with a site in Sweden, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Pancreas Cancer
  • Pancreas Neoplasm
  • Pancreas Cyst
  • Pancreatic Fistula
  • Pancreas Disease
  • Bile Duct Cancer
  • Periampullary Cancer
  • Surgery
  • Surgery--Complications
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No (and still alive at study initiation)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Overall survival

    Overall survival

    Time frame: 10 years

Secondary outcomes

  1. Complications

    Clavien-Dindo, Specific procedure related outcomes

    Time frame: 10 years

  2. Radical resection

    Rates of R0 vs R1/2 resections

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Surgical Clinic at Umeå University Hospital
    Umeå, 90185, Sweden
    Recruiting
    • Oskar Franklin, PhD · Contactoskar.franklin@umu.se · +4690785000
    • Agneta Karhu · Contactagneta.karhu@regionvasterbotten.se
    • Oskar Franklin, MD/PhD · Principal investigator
    • Asif Halimi, MD/PhD · Sub investigator
    • Stina Lindblad, MD · Sub investigator
    • Daniel Öhlund, MD/PhD · Sub investigator
    • Roberto Valente, MD/PhD · Sub investigator
    • Mikael Öman, MD/PhD · Sub investigator
    • Chiara Scandavini, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Jan 2035, 160 months after the start.

Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 160 months is above that.

Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2021
First posted
Dec 14, 2021
StartActual
Sep 1, 2021
Primary completionEst.
Jan 1, 2035
CompletionEst.
Jan 1, 2040
Last update
Jan 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05155878
Lead sponsor
Umeå University
Responsible party
Oskar Franklin (Principal Investigator, Umeå University) — Principal investigator
First posted
Dec 14, 2021
Start date
Sep 1, 2021
Primary completion
Jan 1, 2035 (estimated)
Completion
Jan 1, 2040 (estimated)
Last update
Jan 5, 2022

Study contacts

Oskar Franklin, MD/PhD
Contact
oskar.franklin@umu.se
+4690785000
Asif Halimi, MD
Contact
asif.halimi@regionvasterbotten.se
+4690785000
Oskar Franklin, MD/PhD
principal investigator · Umeå University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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