Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses

NCT04108936 | Recruiting

• 1 other identifier: 15-101-0357
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Peritoneal Carcinomatosis

Keywords

CRS; HIPEC; cellular immune response; microbiomes

Outcome Measures

Primary Outcomes (2)

• Disease free survival

  Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis

  Through study completion, an average of 3 years

• Overall survival

  Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis

  Through study completion, an average of 3 years

Secondary Outcomes (6)

• Renal function (serum creatinine (mg/dl))

  Before as well as during the first 7 days postoperative

• Renal function (urea (mg/dl))

  Before as well as during the first 7 days postoperative

• Renal function (urine output (ml/24h))

  Before as well as during the first 7 days postoperative

• Microbiome (Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers)

  Before as well as at postoperative day 2 and 7

• Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry)

  Before as well as at postoperative day 2 and 7

Study Arms (2)

Peritoneal Carcinomatosis

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

Control group

Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspicious peritoneal carcinomatosis

You may qualify if:

• suspicious peritoneal carcinomatosis

You may not qualify if:

• \<18 years

Sponsors & Collaborators

• University of Regensburg: lead
• Krankenhaus Barmherzige Brüder, Regensburg: collaborator

Study Sites (2)

Krankenhaus der Barmherzigen Brüder Regensburg

Regensburg, Bavaria, 93049, Germany

NOT YET RECRUITING

University Hospital Regensburg

Regensburg, 93053, Germany

RECRUITING

Related Publications (7)

• 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.

  PMID: 21212348 BACKGROUND

• 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.

  PMID: 24531241 BACKGROUND

• 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.

  PMID: 21074069 BACKGROUND

• 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.

  PMID: 22020206 BACKGROUND

• 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.

  PMID: 24777499 BACKGROUND

• 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.

  PMID: 25858803 BACKGROUND

• 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.

  PMID: 37580610 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples; stool samples; tumor samples; Peritoneal tissue

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Matthias Hornung, MD

  Dept. of Surgery, University Hospital Regensburg

  STUDY DIRECTOR

• Jens M Werner, MD

  Dept. of Surgery, University Hospital Regensburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens M Werner, MD

CONTACT

+49941944; Jens.Werner@ukr.de

Monika Diehl-Bein

CONTACT

+49941944; Monika.Diehl-Bein@klinik.uni-regensburg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: September 30, 2019
• Study Start: October 1, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

DE (2)