Peritoneal Carcinomatosis
Conditions
Keywords
CRS, HIPEC, cellular immune response, microbiomes
Brief summary
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.
Interventions
None listed
Sponsors
Krankenhaus Barmherzige Brüder, Regensburg
University of Regensburg
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* suspicious peritoneal carcinomatosis
Exclusion criteria
* \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | Through study completion, an average of 3 years | Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis |
| Overall survival | Through study completion, an average of 3 years | Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function (urine output (ml/24h)) | Before as well as during the first 7 days postoperative | Screening for acute renal insufficiency by measuring urine output (ml/24h) before as well as during the first 7 postoperative days |
| Microbiome (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 | 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. |
| Renal function (serum creatinine (mg/dl)) | Before as well as during the first 7 days postoperative | Screening for acute renal insufficiency by measuring serum chemistry (serum creatinine (mg/dl) before as well as during the first 7 postoperative days |
| Quality of life (Questionnaire-WHOQOL-BREF) | Before surgery and through study completion, an average of 3 years | 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. |
| Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry) | Before as well as at postoperative day 2 and 7 | Longitudinal analysis of cellular immune responses in blood and peritoneal tissue by flow cytometry. Measuring frequency of NK cell populations within total lymphocyte population |
| Renal function (urea (mg/dl)) | Before as well as during the first 7 days postoperative | Screening for acute renal insufficiency by measuring serum chemistry (serum urea (mg/dl) before as well as during the first 7 days postoperative |
Countries
Germany
Contacts
Primary ContactJens M Werner, MD
Backup ContactMonika Diehl-Bein
Outcome results
None listed