Recruiting NCT04108936
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peritoneal Carcinomatosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
Overview
Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
Detailed 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.
Primary outcome measures
- Disease free survival [Time frame: Through study completion, an average of 3 years]
- Overall survival [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (6)
- Renal function (serum creatinine (mg/dl)) [Time frame: Before as well as during the first 7 days postoperative]
- Renal function (urea (mg/dl)) [Time frame: Before as well as during the first 7 days postoperative]
- Renal function (urine output (ml/24h)) [Time frame: 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) [Time frame: 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) [Time frame: Before as well as at postoperative day 2 and 7]
- Quality of life (Questionnaire-WHOQOL-BREF) [Time frame: Before surgery and through study completion, an average of 3 years]
Eligibility criteria
Inclusion criteria
- suspicious peritoneal carcinomatosis
Exclusion criteria
- <18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 2 centers
- Krankenhaus der Barmherzigen Brüder Regensburg — Regensburg
- University Hospital Regensburg — Regensburg
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT04108936 · 15-101-0357