PiCoP-GLOBAL is an international multicenter epidemiological observational study with the goal to develop diagnostic tools for personalized, immune-based therapies in colon and pancreatic tumors. This study is closely connected to the national PiCoP study in Germany and a follow-up vaccination study.
The Peptide-based Immunization for Colon- and Pancreas-Carcinoma Study (PiCoP-GLOBAL) is a global observational study focusing on the identification of tumor-specific neoantigens as the basis for developing a personalized, immune-based therapy to target the patient’s own immune response against the tumor.
Standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. However, since the prognosis of advanced colon cancer and pancreas tumors, in general, is very poor, there is an urgent need for improved treatment.
The enhancement of the immune response via vaccination is among new therapeutic options by using either cell-specific antigens, over-expressed tumor-specific antigens, or mutated tumor-specific antigens (neoepitopes). The biggest potential for high specificity but presuppose an extensive characterization of the respective tumor lies with mutated tumor-specific antigens. In order to identify a neoepitope-based vaccination approach for patient-individualized treatment options, the molecular characteristics of tumors have to first be analyzed.
All patients participating in PiCoP-GLOBAL will be making an important contribution to the understanding of colon and pancreatic tumors, and to the potential development of individualized treatment options.
Participants fulfilling the inclusion criteria will be enrolled in the study after providing informed consent. At the time of standard-of-care surgery to remove the tumor, all participants will have a research blood sample drawn. From the tissue removed during surgical treatment, a tumor sample and a control tissue sample will be obtained for the study.
Additional blood samples may be taken at different time points.
All materials are sent to CENTOGENE and analyzed in CENTOGENE’s laboratory in Germany.
The samples will be tested genetically for tumor-associated mutations and MS/MS-based for neoepitopes and for biomarker studies. The collected data will be used in a multi-omics approach to predict neoepitopes.
Follow-up blood samples will be tested genetically and through specific immune monitoring to verify a pre-existing immune response against neoantigens in non-vaccinated patients, to monitor the patients’ immune response during chemotherapy and to monitor the patients’ response to treatment.
Any patients in which promising neoantigens for vaccine production are found may be offered participation in a future clinical study.
Design: International epidemiological observational non-interventional study
Study population: Patients with pancreas or colorectal carcinoma undergoing surgery
Number of patients: 100 participants
First patient in: April 2019
Last patient in: June 2021
Inclusion period: 24 months
Objectives:
Aim: Development of individualized treatment options for colon and pancreas tumors.
Find out how you can participate: ClinicalTrials.gov
| Inclusion Criteria |
|---|
| Informed consent is obtained from the participant |
| Patients with pancreas or colorectal carcinoma undergoing surgery |
| The participant is older than 18 years old |
CENTOGENE is collaborating for that project with biotech companies, the University of Rostock and the University of Greifswald in the PiCoP study, made possible through co-funding from the European Regional Development Fund (ERDF). In addition to recruiting patients, both universities contribute through scientific projects for PI3K/ATK/mTOR Pathway studies, establishing of cell lines or transplant models, immune monitoring, and epigenetic profiling in colon cancer tissue.
CENTOGENE is also collaborating with international partners for the PiCoP Global Study – with the first international site included in the study in April 2019 with partners in Pakistan (all members of the Surgical Oncology Society Pakistan).
*Source: WHO 2014 World Cancer Report estimates
Prof. Dr. Peter Bauer, Project Lead
CENTOGENE GmbH
Am Strande 7
18055 Rostock
Germany
Email: peter.bauer@centogene.com
Dr. Susann Krake, Project Manager
CENTOGENE GmbH
Am Strande 7
18055 Rostock
Germany
Email: susann.krake@centogene.com
