Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses

NCT ID: NCT04108936

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2028-07-31

Brief Summary

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Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses

Detailed Description

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Cross-sectional and longitudinal analysis of cellular immune responses in the context of disease outcome.

Cross-sectional and longitudinal analysis of the microbiome in the context of disease outcome.

Analysis of renal function with respect of different HIPEC regimens

Identification of clinical surrogate parameters for outcome.

Conditions

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Peritoneal Carcinomatosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Peritoneal Carcinomatosis

Patients suffering from Peritoneal carcinomatoses from either CRC, gastric cancer or primary peritoneal malignancies

No interventions assigned to this group

Control group

Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* suspicious peritoneal carcinomatosis

Exclusion Criteria

* \<18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Barmherzige Brüder, Regensburg

OTHER

Sponsor Role collaborator

University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Hans J Schlitt, Prof. MD

Head of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Hornung, MD

Role: STUDY_DIRECTOR

Dept. of Surgery, University Hospital Regensburg

Jens M Werner, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Surgery, University Hospital Regensburg

Locations

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Krankenhaus der Barmherzigen Brüder Regensburg

Regensburg, Bavaria, Germany

Site Status NOT_YET_RECRUITING

University Hospital Regensburg

Regensburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jens M Werner, MD

Role: CONTACT

+49941944 ext. 6801

Monika Diehl-Bein

Role: CONTACT

+49941944 ext. 6801

Facility Contacts

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Pompiliu Piso, MD

Role: primary

+49 941 3692201

Matthias Hornung, MD

Role: primary

+49 941 944 6832

Jens M Werner, MD

Role: backup

+49 941 944 6944

References

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Vivier E, Raulet DH, Moretta A, Caligiuri MA, Zitvogel L, Lanier LL, Yokoyama WM, Ugolini S. Innate or adaptive immunity? The example of natural killer cells. Science. 2011 Jan 7;331(6013):44-9. doi: 10.1126/science.1198687.

Reference Type BACKGROUND
PMID: 21212348 (View on PubMed)

Mittal D, Gubin MM, Schreiber RD, Smyth MJ. New insights into cancer immunoediting and its three component phases--elimination, equilibrium and escape. Curr Opin Immunol. 2014 Apr;27:16-25. doi: 10.1016/j.coi.2014.01.004. Epub 2014 Feb 14.

Reference Type BACKGROUND
PMID: 24531241 (View on PubMed)

Hoos A, Ibrahim R, Korman A, Abdallah K, Berman D, Shahabi V, Chin K, Canetta R, Humphrey R. Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol. 2010 Oct;37(5):533-46. doi: 10.1053/j.seminoncol.2010.09.015.

Reference Type BACKGROUND
PMID: 21074069 (View on PubMed)

Sharma P, Wagner K, Wolchok JD, Allison JP. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps. Nat Rev Cancer. 2011 Oct 24;11(11):805-12. doi: 10.1038/nrc3153.

Reference Type BACKGROUND
PMID: 22020206 (View on PubMed)

Brahmer JR, Pardoll DM. Immune checkpoint inhibitors: making immunotherapy a reality for the treatment of lung cancer. Cancer Immunol Res. 2013 Aug;1(2):85-91. doi: 10.1158/2326-6066.CIR-13-0078. Epub 2013 Jul 22.

Reference Type BACKGROUND
PMID: 24777499 (View on PubMed)

Miller JF, Sadelain M. The journey from discoveries in fundamental immunology to cancer immunotherapy. Cancer Cell. 2015 Apr 13;27(4):439-49. doi: 10.1016/j.ccell.2015.03.007. Epub 2015 Apr 6.

Reference Type BACKGROUND
PMID: 25858803 (View on PubMed)

Kleber J, Yang Zhou J, Weber F, Bitterer F, Hauer P, Kupke P, Kronenberg K, Geissler EK, Schlitt HJ, Hornung M, Hutchinson JA, Werner JM. Immune profile of patients with peritoneal carcinomatosis selected for CRS-HIPEC therapy. Cancer Immunol Immunother. 2023 Nov;72(11):3867-3873. doi: 10.1007/s00262-023-03515-2. Epub 2023 Aug 14.

Reference Type DERIVED
PMID: 37580610 (View on PubMed)

Other Identifiers

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15-101-0357

Identifier Type: -

Identifier Source: org_study_id

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