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Colon NeoplasmPICOP-GLOBALNCT03871790

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

An observational study of Colon Neoplasm and Colon Adenocarcinoma, run by CENTOGENE GmbH Rostock at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Neoplasm, Colon Adenocarcinoma, Colon Cancer
How many people
50 participants
Where
1 sitePakistan
Study dates
1 Apr 2019to 31 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with colorectal or pancreas carcinoma

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Teaching Hospital UOL Cancer Center

    Lahore

Other trials in Pakistan

About this study

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

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

Read the 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.

Keywords
Neoepitopes, Vaccination, Tumor-specific antigens, Personalized medicine
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03871790
Study groupRoleWhat they receive
Participants with colorectal cancerParticipants with colorectal cancer ongoing surgery older than 18 years old.
Participants with pancreatic cancerParticipants with pancreatic cancer ongoing surgery older than 18 years old.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (2)

  1. 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

    Measured: 24 months

  2. Identification of neo-antigens epitopes at protein level

    Identification of neo-antigens epitopes at protein level via mass spectrography

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion1 Apr 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871790
Sponsor's protocol ID
PICOP-GLOBAL-2019
Acronym
PICOP-GLOBAL
Status last verified
Feb 2023
First submitted
8 Mar 2019
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29545564

  • 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.

    PubMed 27010922

  • 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.

    PubMed 30207593

  • 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.

    PubMed 25934363

  • 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.

    PubMed 17210723

  • 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.

    PubMed 22846827

  • 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.

    PubMed 23563269

  • 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.

    PubMed 19858397

  • 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.

    PubMed 27919280

  • 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.

    PubMed 24090147

  • 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.

    PubMed 25332979

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Neoplasm and Colon Adenocarcinoma, run by CENTOGENE GmbH Rostock at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of tumor specific mutations on the genomic level (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03871790, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.

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