Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses

Peritoneal Carcinomatosis Clinical Trial

— CRS/HIPEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04108936
• Other study ID #: 15-101-0357
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

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