Study on the effects of surgery and HIPEC for peritoneal carcinomatosis
Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
This study is testing how surgery and a special type of heated chemotherapy can affect the immune system and gut bacteria in people with peritoneal carcinomatosis to see how it impacts their health and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Regensburg Academic / other |
| Locations | 2 sites (Regensburg, Bavaria and 1 other locations) |
| Trial ID | NCT04108936 on ClinicalTrials.gov |
What this trial studies
This study conducts a longitudinal analysis of patients with peritoneal carcinomatosis undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). It aims to evaluate cellular immune responses and microbiome changes in relation to disease outcomes. Additionally, the study will assess renal function concerning different HIPEC regimens and identify clinical surrogate parameters that may predict patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with suspicious peritoneal carcinomatosis.
Not a fit: Patients under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses and treatment efficacy in patients with peritoneal carcinomatosis, potentially leading to improved patient outcomes.
How similar studies have performed: While there have been studies on HIPEC, this specific longitudinal approach focusing on immune responses and microbiomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * suspicious peritoneal carcinomatosis Exclusion Criteria: * \<18 years
Where this trial is running
Regensburg, Bavaria and 1 other locations
- Krankenhaus der Barmherzigen Brüder Regensburg — Regensburg, Bavaria, Germany (Not_yet_recruiting)
- University Hospital Regensburg — Regensburg, Germany (Recruiting)
Study contacts
- Principal investigator: Jens M Werner, MD — Dept. of Surgery, University Hospital Regensburg
- Study coordinator: Jens M Werner, MD
- Email: Jens.Werner@ukr.de
- Phone: +49941944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.