Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses

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

Detailed Description
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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.

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

Conditions
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Peritoneal Carcinomatosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspicious peritoneal carcinomatosis Exclusion Criteria: <18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peritoneal Carcinomatosis<br>Patients suffering from Peritoneal carcinomatoses from either CRC, gastric cancer or primary peritoneal malignancies | |
| Control group<br>Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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)) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRS, HIPEC, cellular immune response, microbiomes