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

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ClinicalTrials.gov Identifier: NCT03871790
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centogene AG Rostock

Brief Summary:
Colorectal and pancreatic cancers are among the most common causes of cancer-related death over the world. Patient-individualized treatments and enhancement of the immune response via vaccination are among new therapeutic options. The aim of this study is to identify tumor molecular particularities and neoepitopes among patients with colorectal and pancreatic tumors undergoing surgery.

Condition or disease Intervention/treatment
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 Diagnostic Test: Analysis of molecular tumor particularities and neoepitopes

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peptide-based Immunization for Colon- and Pancreas-carcinoma
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with colorectal cancer
Patients with colorectal cancer ongoing surgery
Diagnostic Test: Analysis of molecular tumor particularities and neoepitopes
Parallel sequencing DNA and RNA from both tumor and blood, as well as analysis of the presence of tumor-specific antigens (neoepitopes) in blood

Patients with pancreatic cancer
Patients with pancreatic cancer ongoing surgery
Diagnostic Test: Analysis of molecular tumor particularities and neoepitopes
Parallel sequencing DNA and RNA from both tumor and blood, as well as analysis of the presence of tumor-specific antigens (neoepitopes) in blood




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Different blood samples will be obtained: blood in EDTA tube, blood in Cell-free DNA tube (Streck tube), and blood in Heparin tube


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with colorectal or pancreas carcinoma
Criteria

Inclusion Criteria:

  • Informed consent is obtained from the participant
  • Patients with pancreas or colorectal carcinoma un-dergoing 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871790


Contacts
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Contact: Peter Bauer, Prof +49-381-80113-510 peter.bauer@centogene.com
Contact: Volha Skrahina, PhD +49-381-80113-594 volha.skrahina@centogene.com

Sponsors and Collaborators
Centogene AG Rostock
Investigators
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Study Chair: Arndt Rolfs, Prof Centogene AG Rostock

Publications:

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Responsible Party: Centogene AG Rostock
ClinicalTrials.gov Identifier: NCT03871790     History of Changes
Other Study ID Numbers: PICOP-GLOBAL-2019
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centogene AG Rostock:
Neoepitopes
Vaccination
Tumor-specific antigens
Personalized medicine

Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Pancrelipase
Vaccines
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs