To hear about similar clinical trials, please enter your email below
Trial Title:
GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
NCT ID:
NCT06102889
Condition:
Pancreatic Adenocarcinoma
Conditions: Official terms:
Neoplasm, Residual
Conditions: Keywords:
Liquid biopsy
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
liquid biopsy
Description:
Taking blood samples (liquid biopsy) for multiple analysis in genomics, proteomics, and
metabolomics
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Gastrocentrum, KarolinskaUniversity Hospital
Address:
City:
Stockholm
Zip:
14186
Country:
Sweden
Start date:
May 2, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Centre Hospitalier Universitaire de Nice
Agency class:
Other
Collaborator:
Agency:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Agency class:
Other
Collaborator:
Agency:
Medical University of Graz
Agency class:
Other
Collaborator:
Agency:
Centre Hospitalier Régional Universitaire Montpellier
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102889
