To hear about similar clinical trials, please enter your email below
Trial Title:
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
NCT ID:
NCT02073500
Condition:
Pseudomyxoma Peritonei
Colorectal Carcinoma
Ovarian Carcinoma
Mesothelioma
Conditions: Official terms:
Carcinoma
Neoplasms
Mesothelioma
Colorectal Neoplasms
Pseudomyxoma Peritonei
Peritoneal Neoplasms
Conditions: Keywords:
Peritoneal carcinomatosis
Peritoneal surface malignancy
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy
CRS
HIPEC
Prognostic biomarker
Predictive biomarker
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational study.
Description:
Analysis of metastatic tissue and blood specimens collected from patients with PSM
undergoing CRS-HIPEC. CRS: Removal of all macroscopically detectable tumor.
HIPEC: Instillation of heated chemotherapy in the abdominal cavity to remove residual
cancer disease.
Arm group label:
Observational study
Other name:
Observational study. Laboratory biomarker analysis.
Summary:
The aim of this study is to identify biomarkers of disease recurrence and prognosis to
optimize patient selection for treatment with cytoreductive surgery (CRS) with
hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore
different treatment strategies for peritoneal surface malignancies (PSM).
Detailed description:
The handling of patients with PSM involves multimodal and multidisciplinary treatment
strategies such as CRS, the removal of all macroscopically detectable tumor, and HIPEC,
instillation of heated chemotherapy in the abdominal cavity to remove residual cancer
disease. The treatment is challenging and complex and associated with significant
morbidity. Only patients with limited disease will benefit from the treatment, and better
methods for patient selection are needed. The project group has a unique opportunity to
address key questions because of acquired experience, an exceptional biobank and
institutional database and novel animal models established at the Norwegian Radium
Hospital.
Criteria for eligibility:
Study pop:
All patients with PSM that are referred to Oslo University Hospital and are candidates
for CRS with HIPEC may be included in the study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- age > 18 years
- confirmed diagnosis of peritoneal surface malignancy
- candidate for CRS-HIPEC
- written informed consent
Exclusion Criteria:
- none
Approximately 80 patients per year will be eligible for inclusion, as this is the number
of patients that annually receive surgical treatment for PSM.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Norwegian Radium Hospital
Address:
City:
Oslo
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Kjersti Flatmark, MD PhD
Phone:
+47 22 93 40 00
Email:
Kjersti.Flatmark@rr-research.no
Contact backup:
Last name:
Annette Torgunrud Kristensen, PhD
Phone:
+47 22 78 19 45
Email:
atj@rr-research.no
Investigator:
Last name:
Kjersti Flatmark, MD PhD
Email:
Principal Investigator
Start date:
September 2009
Completion date:
August 2027
Lead sponsor:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
The Research Council of Norway
Agency class:
Other
Source:
Oslo University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02073500
