Clinical trial NCT04108936: Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
Official title: Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peritoneal Carcinomatosis
Keywords: CRS
HIPEC
cellular immune response
microbiomes
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: Krankenhaus Barmherzige Brüder, Regensburg
First posted: 2019-09-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspicious peritoneal carcinomatosis

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.

Eligibility criteria: Inclusion Criteria:

* suspicious peritoneal carcinomatosis

Exclusion Criteria:

* \<18 years

Primary outcomes:
measure: Disease free survival
timeFrame: Through study completion, an average of 3 years
measure: Overall survival
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Renal function (serum creatinine (mg/dl))
timeFrame: Before as well as during the first 7 days postoperative
measure: Renal function (urea (mg/dl))
timeFrame: Before as well as during the first 7 days postoperative
measure: Renal function (urine output (ml/24h))
timeFrame: Before as well as during the first 7 days postoperative
measure: Microbiome (Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers)
timeFrame: Before as well as at postoperative day 2 and 7
measure: Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry)
timeFrame: Before as well as at postoperative day 2 and 7
measure: Quality of life (Questionnaire-WHOQOL-BREF)
timeFrame: Before surgery and through study completion, an average of 3 years
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Regensburg
state: Bavaria
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: Dept. of Surgery, University Hospital Regensburg
name: Matthias Hornung, MD
role: STUDY_DIRECTOR
affiliation: Dept. of Surgery, University Hospital Regensburg
name: Jens M Werner, MD
role: PRINCIPAL_INVESTIGATOR
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