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

Completed

• Conditions: Rectal Cancer; Rectal Tumors; Pancreatic Cancer; Colon Neoplasm; Colo-rectal Cancer; Rectal Neoplasms; Colon Cancer; Rectal Adenocarcinoma; Pancreas Cancer; Colon Adenocarcinoma

• Registration Number: NCT03871790
• Lead Sponsor: CENTOGENE GmbH Rostock

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-08-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of tumor specific mutations on the genomic level	24 months	Identification of tumor specific mutations on the genomic level using whole exome sequencing and/or whole genome sequencing

Secondary Outcome Measures

Name	Time	Method
Identification of tumor specific mutations on transcriptional and/or translational level	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	24 months	Identification of neo-antigens epitopes at protein level via mass spectrography

Trial Locations

Locations (1)

Teaching Hospital UOL Cancer Center; 🇵🇰 Lahore, Pakistan