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

NCT03871790 | Completed DMC

• 1 other identifier: PICOP-GLOBAL-2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Identification of tumor specific mutations on the genomic level

  Identification of tumor specific mutations on the genomic level using whole exome sequencing and/or whole genome sequencing

  24 months

Secondary Outcomes (2)

• Identification of tumor specific mutations on transcriptional and/or translational level

  24 months

• Identification of neo-antigens epitopes at protein level

  24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal or pancreas carcinoma

You may qualify if:

• Informed consent is obtained from the participant
• Patients with pancreas or colorectal carcinoma undergoing surgery
• The participant is older than 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• CENTOGENE GmbH Rostock: lead

Study Sites (1)

Teaching Hospital UOL Cancer Center

Lahore, Pakistan

Location

Related Publications (11)

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  PMID: 29545564 BACKGROUND

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  PMID: 27010922 BACKGROUND

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  PMID: 30207593 BACKGROUND

• Cho YT, Su H, Wu WJ, Wu DC, Hou MF, Kuo CH, Shiea J. Biomarker Characterization by MALDI-TOF/MS. Adv Clin Chem. 2015;69:209-54. doi: 10.1016/bs.acc.2015.01.001. Epub 2015 Feb 17.

  PMID: 25934363 BACKGROUND

• Dangles-Marie V, Pocard M, Richon S, Weiswald LB, Assayag F, Saulnier P, Judde JG, Janneau JL, Auger N, Validire P, Dutrillaux B, Praz F, Bellet D, Poupon MF. Establishment of human colon cancer cell lines from fresh tumors versus xenografts: comparison of success rate and cell line features. Cancer Res. 2007 Jan 1;67(1):398-407. doi: 10.1158/0008-5472.CAN-06-0594.

  PMID: 17210723 BACKGROUND

• Maule M, Merletti F. Cancer transition and priorities for cancer control. Lancet Oncol. 2012 Aug;13(8):745-6. doi: 10.1016/S1470-2045(12)70268-1. No abstract available.

  PMID: 22846827 BACKGROUND

• 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.

  PMID: 23563269 BACKGROUND

• 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.

  PMID: 19858397 BACKGROUND

• Pompili L, Porru M, Caruso C, Biroccio A, Leonetti C. Patient-derived xenografts: a relevant preclinical model for drug development. J Exp Clin Cancer Res. 2016 Dec 5;35(1):189. doi: 10.1186/s13046-016-0462-4.

  PMID: 27919280 BACKGROUND

• 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.

  PMID: 24090147 BACKGROUND

• Shaw JA, Stebbing J. Circulating free DNA in the management of breast cancer. Ann Transl Med. 2014 Jan;2(1):3. doi: 10.3978/j.issn.2305-5839.2013.06.06.

  PMID: 25332979 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Peter Bauer, Prof.

  CENTOGENE GmbH Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: August 31, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

PA (1)