Peptide-based Immunization for Colon- and and Pancreas-carcinoma (PICOP-GLOBAL)
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|ClinicalTrials.gov Identifier: NCT03871790|
Recruitment Status : Unknown
Verified April 2020 by CENTOGENE GmbH Rostock.
Recruitment status was: Recruiting
First Posted : March 12, 2019
Last Update Posted : April 9, 2021
|Condition or disease|
|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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Peptide-based Immunization for Colon- and Pancreas-carcinoma (PICOP-GLOBAL): An International, Multicenter Protocol|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Participants with colorectal cancer
Participants with colorectal cancer ongoing surgery older than 18 years old.
Participants with pancreatic cancer
Participants with pancreatic cancer ongoing surgery older than 18 years old.
- Identification of tumor specific mutations on the genomic level [ Time Frame: 24 months ]Identification of tumor specific mutations on the genomic level using whole exome sequencing and/or whole genome sequencing
- Identification of tumor specific mutations on transcriptional and/or translational level [ Time Frame: 24 months ]Direct comparison of tumor and non-tumor tissue to identify somatic mutations through RNA sequencing and proteomics analysis
- Identification of neo-antigens epitopes at protein level [ Time Frame: 24 months ]Identification of neo-antigens epitopes at protein level via mass spectrography
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871790
|Contact: Volha Skrahina, PhD||+49 (0)38180113594||Volha.Skrahina@centogene.com|
|Contact: Susann Krake, PhD||+49 (0)38180113530||Susann.Krake@centogene.com|
|Teaching Hospital UOL Cancer Center||Recruiting|
|Contact: Muhammad Arshad Cheema, MD +92 (0)3008017150 firstname.lastname@example.org|
|Principal Investigator: Muhammad Arshad Cheema, MD|
|Principal Investigator:||Peter Bauer, Prof.||CENTOGENE GmbH Rostock|