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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

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