Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses (CRS/HIPEC)

August 19, 2022 updated by: Hans J Schlitt, Prof. MD, University of Regensburg

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Regensburg, Germany, 93053
        • Recruiting
        • University Hospital Regensburg
        • Contact:
        • Contact:
    • Bavaria
      • Regensburg, Bavaria, Germany, 93049

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspicious peritoneal carcinomatosis

Description

Inclusion Criteria:

  • suspicious peritoneal carcinomatosis

Exclusion Criteria:

  • <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Peritoneal Carcinomatosis
Patients suffering from Peritoneal carcinomatoses from either CRC, gastric cancer or primary peritoneal malignancies
Control group
Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: Through study completion, an average of 3 years
Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
Through study completion, an average of 3 years
Overall survival
Time Frame: Through study completion, an average of 3 years
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))
Time Frame: 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
Before as well as during the first 7 days postoperative
Renal function (urea (mg/dl))
Time Frame: 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
Before as well as during the first 7 days postoperative
Renal function (urine output (ml/24h))
Time Frame: 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
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)
Time Frame: 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.
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)
Time Frame: 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
Before as well as at postoperative day 2 and 7
Quality of life (Questionnaire-WHOQOL-BREF)
Time Frame: 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.
Before surgery and through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Collaborators

Krankenhaus Barmherzige Brüder, Regensburg

Investigators

  • Study Director: Matthias Hornung, MD, Dept. of Surgery, University Hospital Regensburg
  • Principal Investigator: Jens M Werner, MD, Dept. of Surgery, University Hospital Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2028

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-101-0357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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