Pancreatic AdenocarcinomaGUIDEMRDNCT06102889
GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
An observational study of Pancreatic Adenocarcinoma, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overall objective of this study is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- liquid biopsy
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2024to 31 Dec 2026
- 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
- Adult, Older adult
Study population: Patients with histologically verified pancreatic adenocarcinoma (from surgically removed tumour tissue = ground truth) regardless of their ability to receive SOC adjuvant chemotherapy or not (observation only - due to pre-existing medical conditions), regardless of type of chemotherapy.
Who may be able to join
- Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
- Age 18 years or older.
- Patient able to understand and sign written informed consent in Swedish.
- Scheduled for curative intent surgical resection.
Who cannot join
- Hereditary pancreatic cancer.
- Verified distant metastases.
- Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
- Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The overall objective of this study is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.
Specifically, we want to determine the association between disease-free survival (DFS) and ctDNA detection status after (1) curative-intended surgery and (2) adjuvant chemotherapy.
Read the detailed description
The study will prospectively enroll patients who undergo potentially curative surgery for PDAC. The intervention is repeated blood sampling at pre-defined time points.
Patient identification Patients with PDAC are screened for eligibility by the involved physicians based on the protocol of the multidisciplinary tumor board (MDT). The screening will be done based on the electronic health record in the electronic journal (at present, for example, Take Care). The National Health Record may be accessed for some patients to complete the record.
Patient recruitment and informed consent The involved physicians screen patients meeting the inclusion criteria specified below. Eligible patients are approached in person or initially by phone, after they have been informed about the diagnosis and the planned surgery. Patients are given written and oral information about the project by a trained research nurse or by an involved physician. Informed consent will be obtained before the beginning of any study-related procedures.
The signed and dated consent forms are scanned into the project's electronic database and stored physically in a locked space.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- liquid biopsy
- Keywords
- Liquid biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid biopsyDiagnostic test
Taking blood samples (liquid biopsy) for multiple analysis in genomics, proteomics, and metabolomics
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pancreatic cancer
Occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.
Measured: 1 month - 24 months after surgical resection of the tumor
Secondary outcomes (1)
Effect of standard-of-care (SOC) chemotherapy on biomarker(s)
Disappearance or re-occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.
Measured: 1 month - 24 months after surgical resection of the tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start2 May 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Aarhus University Hospital, Centre Hospitalier Universitaire de Nice, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Medical University of Graz, Centre Hospitalier Régional Universitaire Montpellier
- Responsible party
- Principal investigator, Matthias Löhr, Karolinska University Hospital
- Investigators
- Claus Lindbjerg Andersen, MD, Study director, Aarhus University Hospitsl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102889
- Sponsor's protocol ID
- GUIDE.MRD-02-PDAC
- Acronym
- GUIDEMRD
- Status last verified
- Apr 2024
- First submitted
- 22 Oct 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completion of the study, the SAB and study group to decide whether to share the results on a group level, i.e. anonymously
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
- ClinicalTrials.gov ID
- NCT06102889
- Acronym / sponsor ID
- GUIDEMRD / GUIDE.MRD-02-PDAC
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Liquid biopsy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Aarhus University Hospital, Centre Hospitalier Universitaire de Nice, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III, Medical University of Graz, Centre Hospitalier Régional Universitaire Montpellier
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2023 (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 this study is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.
Specifically, we want to determine the association between disease-free survival (DFS) and ctDNA detection status after (1) curative-intended surgery and (2) adjuvant chemotherapy.
Detailed description
The study will prospectively enroll patients who undergo potentially curative surgery for PDAC. The intervention is repeated blood sampling at pre-defined time points.
Patient identification Patients with PDAC are screened for eligibility by the involved physicians based on the protocol of the multidisciplinary tumor board (MDT). The screening will be done based on the electronic health record in the electronic journal (at present, for example, Take Care). The National Health Record may be accessed for some patients to complete the record.
Patient recruitment and informed consent The involved physicians screen patients meeting the inclusion criteria specified below. Eligible patients are approached in person or initially by phone, after they have been informed about the diagnosis and the planned surgery. Patients are given written and oral information about the project by a trained research nurse or by an involved physician. Informed consent will be obtained before the beginning of any study-related procedures.
The signed and dated consent forms are scanned into the project's electronic database and stored physically in a locked space.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically verified pancreatic adenocarcinoma (from surgically removed tumour tissue = ground truth) regardless of their ability to receive SOC adjuvant chemotherapy or not (observation only - due to pre-existing medical conditions), regardless of type of chemotherapy.
Key inclusion criteria (4 listed)
- Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
- Age 18 years or older.
- Patient able to understand and sign written informed consent in Swedish.
- Scheduled for curative intent surgical resection.
Key exclusion criteria (4 listed)
- Hereditary pancreatic cancer.
- Verified distant metastases.
- Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
- Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
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 |
|---|---|---|
| liquid biopsyTaking blood samples (liquid biopsy) for multiple analysis in genomics, proteomics, and metabolomics | Diagnostic test | – |
Primary outcome
Recurrence of pancreatic cancer
Time frame: 1 month - 24 months after surgical resection of the tumor
Occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.
1 secondary outcome
Effect of standard-of-care (SOC) chemotherapy on biomarker(s)
Time frame: 1 month - 24 months after surgical resection of the tumor
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 24 Apr 2024.
- Individual participant dataSharing planned: Undecided. After completion of the study, the SAB and study group to decide whether to share the results on a group level, i.e. anonymously
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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.
Claus Lindbjerg Andersen, MD study director
Aarhus University Hospitsl
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 Adenocarcinoma, run by Karolinska University Hospital 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 2024. 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?
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?
Recurrence of pancreatic cancer (time frame: 1 month - 24 months after surgical resection of the tumor). 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 24 Apr 2024.