Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
ConditionPeritoneal Carcinomatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Regensburg
About this trial
Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspicious peritoneal carcinomatosis
Disqualifiers
<18 years
Trial population
Patients with suspicious peritoneal carcinomatosis
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: Peritoneal Carcinomatosis
Group B: Control group
Trial outcomes
Primary outcomes
1
Disease free survival
Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
Time frame
Through study completion, an average of 3 years2
Overall survival
Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis
Time frame
Through study completion, an average of 3 yearsSecondary outcomes
1
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 postoperative2
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 postoperative3
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 postoperative4
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 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regensburg
Lead sponsor
Krankenhaus Barmherzige Brüder, Regensburg
Collaborator
Source ClinicalTrials.gov