Peptide-based Immunization for Colon- and and Pancreas-carcinoma (PICOP-GLOBAL)

February 9, 2023 updated by: CENTOGENE GmbH Rostock

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Teaching Hospital UOL Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal or pancreas carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
Identification of neo-antigens epitopes at protein level
Time Frame: 24 months
Identification of neo-antigens epitopes at protein level via mass spectrography
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CENTOGENE GmbH Rostock

Investigators

  • Principal Investigator: Peter Bauer, Prof., CENTOGENE GmbH Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

April 1, 2022

Study Completion (ACTUAL)

August 31, 2022

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICOP-GLOBAL-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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