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

Pancreatic Cancer Clinical Trial

— PICOP-GLOBAL  

Official title:

Peptide-based Immunization for Colon- and Pancreas-carcinoma (PICOP-GLOBAL): An International, Multicenter Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871790
• Other study ID #: PICOP-GLOBAL-2019
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2023
• Source: CENTOGENE GmbH Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2022
• Est. primary completion date: April 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colo-rectal Cancer
• Colon Adenocarcinoma
• Colon Cancer
• Colon Neoplasm
• Colonic Neoplasms
• Neoplasms
• Pancreas Cancer
• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Rectal Adenocarcinoma
• Rectal Cancer
• Rectal Neoplasms
• Rectal Tumors

Locations

Country	Name	City	State
Pakistan	Teaching Hospital UOL Cancer Center	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
CENTOGENE GmbH Rostock

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

Bobisse S, Genolet R, Roberti A, Tanyi JL, Racle J, Stevenson BJ, Iseli C, Michel A, Le Bitoux MA, Guillaume P, Schmidt J, Bianchi V, Dangaj D, Fenwick C, Derre L, Xenarios I, Michielin O, Romero P, Monos DS, Zoete V, Gfeller D, Kandalaft LE, Coukos G, Harari A. Sensitive and frequent identification of high avidity neo-epitope specific CD8 + T cells in immunotherapy-naive ovarian cancer. Nat Commun. 2018 Mar 15;9(1):1092. doi: 10.1038/s41467-018-03301-0. — View Citation

Bousquet G, Janin A. Patient-Derived Xenograft: An Adjuvant Technology for the Treatment of Metastatic Disease. Pathobiology. 2016;83(4):170-6. doi: 10.1159/000444533. Epub 2016 Mar 25. — View Citation

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identification of tumor specific mutations on transcriptional and/or translational level	Direct comparison of tumor and non-tumor tissue to identify somatic mutations through RNA sequencing and proteomics analysis	24 months
Secondary	Identification of neo-antigens epitopes at protein level	Identification of neo-antigens epitopes at protein level via mass spectrography	24 months