Peritoneal CarcinomatosisCRS/HIPECNCT04108936
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
An observational study of Peritoneal Carcinomatosis, run by University of Regensburg at 2 sites in Germany.
Trial summary
Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal Carcinomatosis
- How many people
- 250 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2016to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspicious peritoneal carcinomatosis
Who may be able to join
- suspicious peritoneal carcinomatosis
Who cannot join
- <18 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Krankenhaus der Barmherzigen Brüder Regensburg
Regensburg, Bavaria, 93049
Pompiliu Piso, MD, +49 941 3692201, pompiliu.piso@barmherzige-regensburg.de
- Recruiting
University Hospital Regensburg
Regensburg, 93053
Matthias Hornung, MD, +49 941 944 6832, matthias.hornung@ukr.de
Jens M Werner, MD, +49 941 944 6944, jens.werner@ukr.de
About this study
Official title: 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
Read the 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.
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- CRS, HIPEC, cellular immune response, microbiomes
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
Measured: Through study completion, an average of 3 years
Overall survival
Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis
Measured: Through study completion, an average of 3 years
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Before surgery and through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startOct 2016
- Primary completionJul 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus Barmherzige Brüder, Regensburg
- Responsible party
- Principal investigator, Hans J Schlitt, Prof. MD, University of Regensburg
- Investigators
- Matthias Hornung, MD, Study director, Dept. of Surgery, University Hospital RegensburgJens M Werner, MD, Principal investigator, Dept. of Surgery, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108936
- Sponsor's protocol ID
- 15-101-0357
- Acronym
- CRS/HIPEC
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2017
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Vivier E, Raulet DH, Moretta A, Caligiuri MA, Zitvogel L, Lanier LL, Yokoyama WM, Ugolini S. Innate or adaptive immunity? The example of natural killer cells. Science. 2011 Jan 7;331(6013):44-9. doi: 10.1126/science.1198687.
PubMed 21212348Mittal D, Gubin MM, Schreiber RD, Smyth MJ. New insights into cancer immunoediting and its three component phases--elimination, equilibrium and escape. Curr Opin Immunol. 2014 Apr;27:16-25. doi: 10.1016/j.coi.2014.01.004. Epub 2014 Feb 14.
PubMed 24531241Hoos A, Ibrahim R, Korman A, Abdallah K, Berman D, Shahabi V, Chin K, Canetta R, Humphrey R. Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol. 2010 Oct;37(5):533-46. doi: 10.1053/j.seminoncol.2010.09.015.
PubMed 21074069Sharma P, Wagner K, Wolchok JD, Allison JP. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps. Nat Rev Cancer. 2011 Oct 24;11(11):805-12. doi: 10.1038/nrc3153.
PubMed 22020206Brahmer JR, Pardoll DM. Immune checkpoint inhibitors: making immunotherapy a reality for the treatment of lung cancer. Cancer Immunol Res. 2013 Aug;1(2):85-91. doi: 10.1158/2326-6066.CIR-13-0078. Epub 2013 Jul 22.
PubMed 24777499Miller JF, Sadelain M. The journey from discoveries in fundamental immunology to cancer immunotherapy. Cancer Cell. 2015 Apr 13;27(4):439-49. doi: 10.1016/j.ccell.2015.03.007. Epub 2015 Apr 6.
PubMed 25858803Kleber J, Yang Zhou J, Weber F, Bitterer F, Hauer P, Kupke P, Kronenberg K, Geissler EK, Schlitt HJ, Hornung M, Hutchinson JA, Werner JM. Immune profile of patients with peritoneal carcinomatosis selected for CRS-HIPEC therapy. Cancer Immunol Immunother. 2023 Nov;72(11):3867-3873. doi: 10.1007/s00262-023-03515-2. Epub 2023 Aug 14.
PubMed 37580610
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
- ClinicalTrials.gov ID
- NCT04108936
- Acronym / sponsor ID
- CRS/HIPEC / 15-101-0357
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- CRS, HIPEC, cellular immune response, microbiomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Krankenhaus Barmherzige Brüder, Regensburg
- Study start
- Oct 2016
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicious peritoneal carcinomatosis
Key inclusion criteria (1 listed)
- suspicious peritoneal carcinomatosis
Key exclusion criteria (1 listed)
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease free survival
Time frame: Through study completion, an average of 3 years
Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
Overall survival
Time frame: Through study completion, an average of 3 years
Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis
6 secondary outcomes
Renal function (serum creatinine (mg/dl))
Time frame: 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
Renal function (urine output (ml/24h))
Time frame: 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
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
Quality of life (Questionnaire-WHOQOL-BREF)
Time frame: Before surgery and through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 21212348Vivier E, Raulet DH, Moretta A, Caligiuri MA, Zitvogel L, Lanier LL, Yokoyama WM, Ugolini S. Innate or adaptive immunity? The example of natural killer cells. Science. 2011 Jan 7;331(6013):44-9. doi: 10.1126/science.1198687.
- Background: PubMed 24531241Mittal D, Gubin MM, Schreiber RD, Smyth MJ. New insights into cancer immunoediting and its three component phases--elimination, equilibrium and escape. Curr Opin Immunol. 2014 Apr;27:16-25. doi: 10.1016/j.coi.2014.01.004. Epub 2014 Feb 14.
- Background: PubMed 21074069Hoos A, Ibrahim R, Korman A, Abdallah K, Berman D, Shahabi V, Chin K, Canetta R, Humphrey R. Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol. 2010 Oct;37(5):533-46. doi: 10.1053/j.seminoncol.2010.09.015.
- Background: PubMed 22020206Sharma P, Wagner K, Wolchok JD, Allison JP. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps. Nat Rev Cancer. 2011 Oct 24;11(11):805-12. doi: 10.1038/nrc3153.
- Background: PubMed 24777499Brahmer JR, Pardoll DM. Immune checkpoint inhibitors: making immunotherapy a reality for the treatment of lung cancer. Cancer Immunol Res. 2013 Aug;1(2):85-91. doi: 10.1158/2326-6066.CIR-13-0078. Epub 2013 Jul 22.
- Background: PubMed 25858803Miller JF, Sadelain M. The journey from discoveries in fundamental immunology to cancer immunotherapy. Cancer Cell. 2015 Apr 13;27(4):439-49. doi: 10.1016/j.ccell.2015.03.007. Epub 2015 Apr 6.
- Derived from this study: PubMed 37580610Kleber J, Yang Zhou J, Weber F, Bitterer F, Hauer P, Kupke P, Kronenberg K, Geissler EK, Schlitt HJ, Hornung M, Hutchinson JA, Werner JM. Immune profile of patients with peritoneal carcinomatosis selected for CRS-HIPEC therapy. Cancer Immunol Immunother. 2023 Nov;72(11):3867-3873. doi: 10.1007/s00262-023-03515-2. Epub 2023 Aug 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Hornung, MD study director
Dept. of Surgery, University Hospital Regensburg
Jens M Werner, MD principal investigator
Dept. of Surgery, University Hospital Regensburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Carcinomatosis, run by University of Regensburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens M Werner, MD (+49941944 ext. 6801, Jens.Werner@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108936, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.