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Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies (PSM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oslo University Hospital
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT02073500
First received: February 17, 2014
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention
Pseudomyxoma Peritonei.
Colorectal Carcinoma.
Ovarian Carcinoma.
Mesothelioma.
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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Metastatic tissue, blood specimens.


Estimated Enrollment: 200
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)
Groups/Cohorts Assigned Interventions
Observational study
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with PSM that are referred to Oslo University Hospital and are candidates for CRS with HIPEC may be included in the study.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073500

Contacts
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 atj@ous-hf.no

Locations
Norway
The Norwegian Radium Hospital Recruiting
Oslo, Norway
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    atj@ous-hf.no   
Principal Investigator: Kjersti Flatmark, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
Principal Investigator: Kjersti Flatmark, MD PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02073500     History of Changes
Other Study ID Numbers: PSM_250913
Study First Received: February 17, 2014
Last Updated: October 22, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Peritoneal carcinomatosis
Peritoneal surface malignancy
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy
CRS
HIPEC
Prognostic biomarker
Predictive biomarker

Additional relevant MeSH terms:
Genital Diseases, Female
Carcinoma
Colorectal Neoplasms
Mesothelioma
Neoplasms
Neoplasms, Mesothelial
Ovarian Neoplasms
Pseudomyxoma Peritonei
Adenoma
Adnexal Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Neoplasms, Female
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Rectal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014