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

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ClinicalTrials.gov Identifier: NCT03871790
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Centogene AG Rostock

Tracking Information
First Submitted Date March 8, 2019
First Posted Date March 12, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03871790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 11, 2019)
  • 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
  • Identification of neo-antigens epitopes at protein level [ Time Frame: 24 months ]
    Identification of neo-antigens epitopes at protein level via mass spectrography
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Peptide-based Immunization for Colon- and and Pancreas-carcinoma
Official Title Peptide-based Immunization for Colon- and Pancreas-carcinoma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Different blood samples will be obtained: blood in EDTA tube, blood in Cell-free DNA tube (Streck tube), and blood in Heparin tube
Sampling Method Non-Probability Sample
Study Population Patients with colorectal or pancreas carcinoma
Condition
  • 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
Intervention 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
Study Groups/Cohorts
  • Patients with colorectal cancer
    Patients with colorectal cancer ongoing surgery
    Intervention: Diagnostic Test: Analysis of molecular tumor particularities and neoepitopes
  • Patients with pancreatic cancer
    Patients with pancreatic cancer ongoing surgery
    Intervention: Diagnostic Test: Analysis of molecular tumor particularities and neoepitopes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 11, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Peter Bauer, Prof +49-381-80113-510 peter.bauer@centogene.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03871790
Other Study ID Numbers PICOP-GLOBAL-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Centogene AG Rostock
Study Sponsor Centogene AG Rostock
Collaborators Not Provided
Investigators
Study Chair: Arndt Rolfs, Prof Centogene AG Rostock
PRS Account Centogene AG Rostock
Verification Date March 2019