Duodenal CancerNCT05134961
Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma
An observational study of Duodenal Cancer, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Cancer
- What is being tested?
- Pancreaduodenectomy and possible adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 1999to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients subjected to resection of primary duodenal adenocarcinoma
Who may be able to join
- Patients subjected to resection of primary duodenal adenocarcinoma
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.
- Conditions
- Duodenal Cancer
- Being tested
- Pancreaduodenectomy and possible adjuvant therapy
- Medical subject headings
- Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaduodenectomy and possible adjuvant therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pancreaduodenectomy and possible adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year survival
Cumulative survival after three years
Measured: Three years
Secondary outcomes (1)
Duodenal cancer recurrence
Recurrence found by computed tomography scan
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Jan 1999
- Primary completion31 Aug 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kiim Jensen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134961
- Sponsor's protocol ID
- Duodenal adenocarcinoma
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05134961
- Acronym / sponsor ID
- Duodenal adenocarcinoma
- Conditions
- Duodenal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Nov 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 aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing resection of primary duodenal cancer | – | Procedure: Pancreaduodenectomy and possible adjuvant therapyTumors comprised histologically confirmed adenocarcinomas in the duodenum excluding adenocarcinoma of the ampulla of Vater and adenocarcinomas with gastric and pancreato-biliary morphology and immunohistochemistry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients subjected to resection of primary duodenal adenocarcinoma
Key inclusion criteria (1 listed)
- Patients subjected to resection of primary duodenal adenocarcinoma
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreaduodenectomy and possible adjuvant therapyAdjuvant 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. | Procedure or surgery | Patients undergoing resection of primary duodenal cancer |
Primary outcome
3-year survival
Time frame: Three years
Cumulative survival after three years
1 secondary outcome
Duodenal cancer recurrence
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Duodenal Cancer, run by Bispebjerg Hospital at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 26 Nov 2021. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year survival (time frame: Three 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 26 Nov 2021.