We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    picop
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871790
Recruitment Status : Unknown
Verified April 2020 by CENTOGENE GmbH Rostock.
Recruitment status was:  Recruiting
First Posted : March 12, 2019
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peptide-based Immunization for Colon- and Pancreas-carcinoma (PICOP-GLOBAL): An International, Multicenter Protocol
Actual 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
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.



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
Blood in EDTA tube, blood in Cell-free DNA tube (Streck tube), and blood in Heparin tube


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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
Layout table for location contacts
Contact: Volha Skrahina, PhD +49 (0)38180113594 Volha.Skrahina@centogene.com
Contact: Susann Krake, PhD +49 (0)38180113530 Susann.Krake@centogene.com

Locations
Layout table for location information
Pakistan
Teaching Hospital UOL Cancer Center Recruiting
Lahore, Pakistan
Contact: Muhammad Arshad Cheema, MD    +92 (0)3008017150    cancersurgerypk@gmail.com   
Principal Investigator: Muhammad Arshad Cheema, MD         
Sponsors and Collaborators
CENTOGENE GmbH Rostock
Investigators
Layout table for investigator information
Principal Investigator: Peter Bauer, Prof. CENTOGENE GmbH Rostock
Publications:

Layout table for additonal information
Responsible Party: CENTOGENE GmbH Rostock
ClinicalTrials.gov Identifier: NCT03871790    
Other Study ID Numbers: PICOP-GLOBAL-2019
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CENTOGENE GmbH Rostock:
Neoepitopes
Vaccination
Tumor-specific antigens
Personalized medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Adenocarcinoma
Pancreatic Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases