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NCT Number: NCT03871790

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

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

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Identification of neo-antigens epitopes at protein level

    Time frame: 24 months

    Identification of neo-antigens epitopes at protein level via mass spectrography

Sponsors and collaborators

Lead sponsor

CENTOGENE GmbH Rostock

Industry

Registry information

Official study title

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

Acronym: PICOP-GLOBAL

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2019
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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