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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04108936
Other study ID # 15-101-0357
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2016
Est. completion date July 2028

Study information

Verified date August 2022
Source University of Regensburg
Contact Jens M Werner, MD
Phone +49941944
Email Jens.Werner@ukr.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date July 2028
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - suspicious peritoneal carcinomatosis Exclusion Criteria: - <18 years

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Krankenhaus der Barmherzigen Brüder Regensburg Regensburg Bavaria
Germany University Hospital Regensburg Regensburg

Sponsors (2)

Lead Sponsor Collaborator
University of Regensburg Krankenhaus Barmherzige Brüder, Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disease free survival Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis Through study completion, an average of 3 years
Primary Overall survival Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis Through study completion, an average of 3 years
Secondary Renal function (serum creatinine (mg/dl)) Screening for acute renal insufficiency by measuring serum chemistry (serum creatinine (mg/dl) before as well as during the first 7 postoperative days Before as well as during the first 7 days postoperative
Secondary Renal function (urea (mg/dl)) Screening for acute renal insufficiency by measuring serum chemistry (serum urea (mg/dl) before as well as during the first 7 days postoperative Before as well as during the first 7 days postoperative
Secondary Renal function (urine output (ml/24h)) Screening for acute renal insufficiency by measuring urine output (ml/24h) before as well as during the first 7 postoperative days Before as well as during the first 7 days postoperative
Secondary Microbiome (Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers) Longitudinal analysis of the microbial burden within samples will be quantified with droplet digital polymerase chain reaction. 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
Secondary Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry) Longitudinal analysis of cellular immune responses in blood and peritoneal tissue by flow cytometry. Measuring frequency of NK cell populations within total lymphocyte population Before as well as at postoperative day 2 and 7
Secondary Quality of life (Questionnaire-WHOQOL-BREF) Prospective analysis of quality of life after CRS/HIPEC for peritoneal carcinomatosis. Questionnaire-WHOQOL-BRE produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain (Physical health (Score 7-35), Psychological (Score 6-30), Social relationships (Score 3-15), Environment (Score 8-40)). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score transformed to 4-20 or 20-100. Before surgery and through study completion, an average of 3 years
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