An observational study in Peritoneal Carcinomatosis, sponsored by University of Regensburg. Recruiting at 2 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by University of Regensburg · Observational
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.
249 studies on the registry are indexed under Peritoneal Neoplasms; 55 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 43 observational studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →University of Regensburg is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with suspicious peritoneal carcinomatosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients suffering from Peritoneal carcinomatoses from either CRC, gastric cancer or primary peritoneal malignancies
Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis
Disease free survival
Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
Time frame: Through study completion, an average of 3 years
Overall survival
Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis
Time frame: Through study completion, an average of 3 years
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
Time frame: Before as well as during the first 7 days postoperative
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
Time frame: 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
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)
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.
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)
Longitudinal analysis of cellular immune responses in blood and peritoneal tissue by flow cytometry. Measuring frequency of NK cell populations within total lymphocyte population
Time frame: 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.
Time frame: Before surgery and through study completion, an average of 3 years
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University of Regensburg