Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - Characterization, Models and Treatment Strategies.

Conditions
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Pseudomyxoma Peritonei, Colorectal Carcinoma, Ovarian Carcinoma, Mesothelioma

Intervention / Treatment
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* Other: Observational study.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational study<br>Patients diagnosed with PSM undergoing CRS with HIPEC. | Other: Observational study.<br>* 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.<br>* Other names: Observational study. Laboratory biomarker analysis.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Time from surgery until death from any cause | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | Time from surgery until disease recurrence or death | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal carcinomatosis, Peritoneal surface malignancy, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, CRS, HIPEC, Prognostic biomarker, Predictive biomarker