Clinical trial NCT03871790: Peptide-based Immunization for Colon- and and Pancreas-carcinoma
Official title: Peptide-based Immunization for Colon- and Pancreas-carcinoma (PICOP-GLOBAL): An International, Multicenter Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Neoepitopes
Vaccination
Tumor-specific antigens
Personalized medicine
Lead sponsor: CENTOGENE GmbH Rostock
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal or pancreas carcinoma

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of tumor specific mutations on the genomic level
timeFrame: 24 months
Secondary outcomes:
measure: Identification of tumor specific mutations on transcriptional and/or translational level
timeFrame: 24 months
measure: Identification of neo-antigens epitopes at protein level
timeFrame: 24 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Teaching Hospital UOL Cancer Center
Study officials:
affiliation: CENTOGENE GmbH Rostock
name: Peter Bauer, Prof.
role: PRINCIPAL_INVESTIGATOR
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