Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

NCT ID: NCT02073500

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2027-08-31

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.

Conditions

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Pseudomyxoma Peritonei Colorectal Carcinoma Ovarian Carcinoma Mesothelioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational study

Patients diagnosed with PSM undergoing CRS with HIPEC.

Observational study.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Observational study. Laboratory biomarker analysis.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kjersti Flatmark

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kjersti Flatmark, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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The Norwegian Radium Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Kjersti Flatmark, MD PhD

Role: CONTACT

+47 22 93 40 00

Annette Torgunrud Kristensen, PhD

Role: CONTACT

+47 22 78 19 45

Facility Contacts

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Kjersti Flatmark, MD PhD

Role: primary

+47 22 93 40 00

Annette Torgunrud Kristensen, PhD

Role: backup

+47 22 78 19 45

References

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Lund-Andersen C, Nakken S, Nygard S, Fromm B, Aasheim LB, Davidson B, Julsrud L, Abrahamsen TW, Kristensen AT, Dybdahl B, Larsen SG, Hovig E, Flatmark K. Integrative genomic analysis of peritoneal malignant mesothelioma: understanding a case with extraordinary chemotherapy response. Cold Spring Harb Mol Case Stud. 2019 Apr 1;5(2):a003566. doi: 10.1101/mcs.a003566. Print 2019 Apr.

Reference Type DERIVED
PMID: 30862609 (View on PubMed)

Other Identifiers

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PSM_250913

Identifier Type: -

Identifier Source: org_study_id

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