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| Name | Class |
|---|---|
| Krankenhaus Barmherzige Brüder, Regensburg | OTHER |
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Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Renal function (urea (mg/dl)) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with suspicious peritoneal carcinomatosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens M Werner, MD | Contact | +49941944 | 6801 | Jens.Werner@ukr.de |
| Monika Diehl-Bein | Contact | +49941944 | 6801 | Monika.Diehl-Bein@klinik.uni-regensburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Hornung, MD | Dept. of Surgery, University Hospital Regensburg | Study Director |
| Jens M Werner, MD | Dept. of Surgery, University Hospital Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Barmherzigen Brüder Regensburg | Not yet recruiting | Regensburg | Bavaria | 93049 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21212348 | Background | 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. | |
| 24531241 | 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. |
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| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
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blood samples; stool samples; tumor samples; Peritoneal tissue
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| University Hospital Regensburg | Recruiting | Regensburg | 93053 | Germany |
|
| 21074069 | 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. |
| 22020206 | 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. |
| 24777499 | 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. |
| 25858803 | 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. |
| 37580610 | Derived | 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. |
| D004066 |
| Digestive System Diseases |
| D010532 | Peritoneal Diseases |