Pancreatic NeoplasmsNCT04947696
Circulating Epigenetics in Pancreatic Surgery
An observational study of Pancreatic Neoplasms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Blood sampling
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jul 2021to 1 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pancreatic cancer patients
Who may be able to join
- Patients with pancreatic cancer scheduled for the Whipples procedure
Who cannot join
- Under 18 years of age
- Pregnancy
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2300
Martin Sillesen, MD, PhD, 35452122, martin.sillesen@regionh.dk
Martin Sillesen, MD, PhD
About this study
Official title: Towards Precision Medicine in Pancreatic Surgery - an Integrative Approach Combining Deep Learning, Genetics and Epigenetics
The overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner
- Conditions
- Pancreatic Neoplasms
- Being tested
- Blood sampling
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Blood sampling preoperatively and sequentially up to 30 days post op
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing a Whipples procedure for pancreatic cancer Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DNA-methylation patterns from the pre to postoperative setting
Measured: Up to 30 days postoperatively
Secondary outcomes (2)
Occurence of a postoperative complication
Measured: 30 days postoperatively
Relapse of pancreatic cancer
Measured: 2 years from time of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sillesen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947696
- Sponsor's protocol ID
- 70711
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Precision Medicine in Pancreatic Surgery - an Integrative Approach Combining Deep Learning, Genetics and Epigenetics
- ClinicalTrials.gov ID
- NCT04947696
- Acronym / sponsor ID
- 70711
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 1 Jul 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 overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Blood samplingPatients undergoing a Whipples procedure for pancreatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer patients
Key inclusion criteria (1 listed)
- Patients with pancreatic cancer scheduled for the Whipples procedure
Key exclusion criteria (3 listed)
- Under 18 years of age
- Pregnancy
- Unable to provide informed consent.
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 |
|---|---|---|
| Blood samplingBlood sampling preoperatively and sequentially up to 30 days post op | Diagnostic test | 1 |
Primary outcome
Changes in DNA-methylation patterns from the pre to postoperative setting
Time frame: Up to 30 days postoperatively
2 secondary outcomes
Occurence of a postoperative complication
Time frame: 30 days postoperatively
Relapse of pancreatic cancer
Time frame: 2 years from time of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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.
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 Pancreatic Neoplasms, run by Copenhagen University Hospital, Rigshospitalet 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 3 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: status not confirmed, as of the sponsor's last update on 1 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DNA-methylation patterns from the pre to postoperative setting (time frame: Up to 30 days postoperatively). 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 1 Jul 2021.