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

NCT ID: NCT03871790

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with colorectal cancer

Participants with colorectal cancer ongoing surgery older than 18 years old.

No interventions assigned to this group

Participants with pancreatic cancer

Participants with pancreatic cancer ongoing surgery older than 18 years old.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CENTOGENE GmbH Rostock

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Bauer, Prof.

Role: PRINCIPAL_INVESTIGATOR

CENTOGENE GmbH Rostock

Locations

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Teaching Hospital UOL Cancer Center

Lahore, , Pakistan

Site Status

Countries

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Pakistan

References

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Murtaza M, Dawson SJ, Tsui DW, Gale D, Forshew T, Piskorz AM, Parkinson C, Chin SF, Kingsbury Z, Wong AS, Marass F, Humphray S, Hadfield J, Bentley D, Chin TM, Brenton JD, Caldas C, Rosenfeld N. Non-invasive analysis of acquired resistance to cancer therapy by sequencing of plasma DNA. Nature. 2013 May 2;497(7447):108-12. doi: 10.1038/nature12065. Epub 2013 Apr 7.

Reference Type BACKGROUND
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Philip PA, Mooney M, Jaffe D, Eckhardt G, Moore M, Meropol N, Emens L, O'Reilly E, Korc M, Ellis L, Benedetti J, Rothenberg M, Willett C, Tempero M, Lowy A, Abbruzzese J, Simeone D, Hingorani S, Berlin J, Tepper J. Consensus report of the national cancer institute clinical trials planning meeting on pancreas cancer treatment. J Clin Oncol. 2009 Nov 20;27(33):5660-9. doi: 10.1200/JCO.2009.21.9022. Epub 2009 Oct 26.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Rammensee HG, Singh-Jasuja H. HLA ligandome tumor antigen discovery for personalized vaccine approach. Expert Rev Vaccines. 2013 Oct;12(10):1211-7. doi: 10.1586/14760584.2013.836911. Epub 2013 Oct 4.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 25332979 (View on PubMed)

Other Identifiers

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PICOP-GLOBAL-2019

Identifier Type: -

Identifier Source: org_study_id

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