Pancreas CancerNCT05155878
Prognostic Factors in Periampullary Tumors and Cysts
An observational study of Pancreas Cancer and Pancreas Neoplasm, run by Umeå University at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Cyst
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 1 Jan 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have been recommended or already undergone surgery for a cyst or tumor in the pancreas or periampullary region
Who may be able to join
- 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)
Who cannot join
- No informed consent (and still alive at study initiation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Surgical Clinic at Umeå University Hospital
Umeå, 90185
Oskar Franklin, PhD, +4690785000, oskar.franklin@umu.se
Agneta Karhu, agneta.karhu@regionvasterbotten.se
About this study
Official title: Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region
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.
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Cyst, Pancreatic Fistula, Pancreas Disease, Bile Duct Cancer
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Cyst, Pancreatic Fistula, Pancreatic Diseases, Bile Duct Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 10 years
Secondary outcomes (2)
Complications
Clavien-Dindo, Specific procedure related outcomes
Measured: 10 years
Radical resection
Rates of R0 vs R1/2 resections
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Sep 2021
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oskar Franklin, Umeå University
- Investigators
- Oskar Franklin, MD/PhD, Principal investigator, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155878
- Sponsor's protocol ID
- UmU-parpanc
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region
- ClinicalTrials.gov ID
- NCT05155878
- Acronym / sponsor ID
- UmU-parpanc
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Cyst, Pancreatic Fistula, Pancreas Disease, Bile Duct Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2040 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have been recommended or already undergone surgery for a cyst or tumor in the pancreas or periampullary region
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- No informed consent (and still alive at study initiation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 10 years
Overall survival
2 secondary outcomes
Complications
Time frame: 10 years
Radical resection
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
Related trials for Pancreas Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oskar Franklin, MD/PhD principal investigator
University Hospital, Umeå
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Pancreas Neoplasm, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oskar Franklin, MD/PhD (+4690785000, oskar.franklin@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.