To identify and synthesise patient-specific neoantigen peptides from residual material of resected pancreatic cancer tissue, from the organoids established from the resected pancreatic cancer tissue (MEC-2021-0325) and from peripheral blood.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are identifying patient-specific neoantigens from PDAC
tumour material, evaluating the feasibility and efficacy of our peptide
production laboratory in synthesising the predicted neoantigens as peptides and
testing their in vitro immunogenicity to elicit tumour-specific T cells.
Secondary outcome
Secondary endpoints are to identify patient-specific neoantigens from PDAC
organoids and their immunogenicity and to conduct comprehensive oncologic,
molecular and immunological analyses, including but not limited to RNA-based
immune infiltration analysis, DNA damage repair analysis, single-cell
sequencing, TCR sequencing, and spatial biology analysis.
Background summary
Pancreatic cancer is notorious for its aggressive nature and poor prognosis.
Traditional treatment options such as chemotherapy and radiation therapy have
limited efficacy. By studying neoantigens, which are patient- and
tumour-specific due to somatic mutations, it becomes possible to develop
personalised immunotherapies tailored to target these specific antigens. This
approach holds promise for improving treatment outcomes by harnessing the
immune system of a patient to target and destroy cancer cells selectively.
Study objective
To identify and synthesise patient-specific neoantigen peptides from residual
material of resected pancreatic cancer tissue, from the organoids established
from the resected pancreatic cancer tissue (MEC-2021-0325) and from peripheral
blood.
Study design
This is a prospective single-centre, translational, proof-of-concept study. The
study design consists of one additional blood draw prior to or during routine
surgery for pancreatic cancer. In addition, we will collect residual tumour
material. The blood as well as DNA and RNA extracted from the residual material
of the resected tumour specimen, will be used to identify patient-specific
neoantigens. We will collect one additional sample of 60 ml of peripheral blood
for each patient.
Study burden and risks
Patients will not have to visit the hospital for additional visits during this
study. Signing of Informed Consent will occur after they have been scheduled
for routine surgery, preferably on the day of their visit to the anaesthesia
department. The only intervention during this study is the collection of
additional blood from an existing venous access during standard-of-care
surgery. This intervention is associated with very minor discomfort, such as
bruising. In addition, residual tissue will be collected with no associated
risks or burdens. Overall, the additional burden and risks are negligible.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must meet all the
following criteria:
• Histological or cytological (Bethesda 5 or 6) confirmed PDAC, as indicated by
a definite cytology/histology report.
• Scheduled for surgical removal of the pancreatic tumour.
• Age >= 18 years.
• Provision of written informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Diagnosis of immunodeficiency.
• Received systemic steroid therapy or any other form of immunosuppressive
therapy within 14 days before the screening. The following are exceptions to
this criterion:
o Intranasal, inhaled, topical steroids, or local steroid injections (e.g.,
intra-articular injection).
o Systemic corticosteroids.
o Steroids as premedication for hypersensitivity reactions (e.g., CT scan
premedication).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87964.078.24 |