Peptide-based Immunization for Colon- and and Pancreas-carcinoma

Study Overview
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Brief Summary
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An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.

Detailed Description
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Colorectal and pancreatic cancers are among the most common causes of cancer-related death over the world. Standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. However, the current statistics underlines an urgent need for improved treatment. Patient-individualized treatments and enhancement of the immune response via vaccination are among new therapeutic options. The enhancement of the immune response via vaccination is among new therapeutic options. Here, either cell-specific antigens, over-expressed tumor specific antigens or mutated tumor-specific antigens (neoepitopes) can be employed. Especially the latter possess the biggest potential for high specificity but presuppose an extensive characterization of the respective tumor. In order to identify a neoepitope-based vaccination approach for patient-individualized treatment options the molecular particularities of tumors have to be analysed. The aim of this study is to identify tumor molecular particularities and neoepitopes among patients with colorectal and pancreatic tumors undergoing surgery.

Official Title
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Peptide-based Immunization for Colon- and Pancreas-carcinoma (PICOP-GLOBAL): An International, Multicenter Protocol

Conditions
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Colon Neoplasm, Colon Adenocarcinoma, Colon Cancer, Colo-rectal Cancer, Rectal Cancer, Rectal Neoplasms, Rectal Adenocarcinoma, Rectal Tumors, Pancreatic Cancer, Pancreas Cancer, Pancreatic Neoplasms, Pancreatic Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Inability to provide informed consent The patient is not suffering from pancreas or colo-rectal carcinoma Patient has a condition contradicting surgery The participant is younger than 18 years old Previously enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with colorectal cancer<br>Participants with colorectal cancer ongoing surgery older than 18 years old. | |
| Participants with pancreatic cancer<br>Participants with pancreatic cancer ongoing surgery older than 18 years old. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of tumor specific mutations on the genomic level | Identification of tumor specific mutations on the genomic level using whole exome sequencing and/or whole genome sequencing | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of tumor specific mutations on transcriptional and/or translational level | Direct comparison of tumor and non-tumor tissue to identify somatic mutations through RNA sequencing and proteomics analysis | 24 months | 
| Identification of neo-antigens epitopes at protein level | Identification of neo-antigens epitopes at protein level via mass spectrography | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoepitopes, Vaccination, Tumor-specific antigens, Personalized medicine