Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies (PSM)
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).
Other: Observational study.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||5 Years|
|Official Title:||Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - Characterization, Models and Treatment Strategies.|
- Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Metastatic tissue, blood specimens.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||January 2023|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Patients diagnosed with PSM undergoing CRS with HIPEC.
Other: Observational study.
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.
Other Name: Observational study. Laboratory biomarker analysis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02073500
|Contact: Kjersti Flatmark, MD PhD||+47 22 78 18 73||Kjersti.Flatmark@rr-research.no|
|Contact: Annette Torgunrud Kristensen, PhD||+47 22 78 23 firstname.lastname@example.org|
|The Norwegian Radium Hospital||Recruiting|
|Contact: Kjersti Flatmark, MD PhD +47 22 78 18 73 Kjersti.Flatmark@rr-research.no|
|Contact: Annette Torgunrud Kristensen, PhD +47 22 78 23 12 email@example.com|
|Principal Investigator: Kjersti Flatmark, MD PhD|
|Principal Investigator:||Kjersti Flatmark, MD PhD||Oslo University Hospital|