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NCT Number: NCT02073500

Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

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).

Recruiting

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Key information

Conditions

Pseudomyxoma Peritonei Abdominal Neoplasms Adenocarcinoma Adenocarcinoma, Mucinous Adenoma Adnexal Diseases Carcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Mesothelioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Peritoneal Diseases Peritoneal Neoplasms Rectal Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational study.

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.

Other names: Observational study. Laboratory biomarker analysis.

Primary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    Time from surgery until death from any cause

Secondary outcomes

  1. Disease-free survival (DFS)

    Time frame: 5 years

    Time from surgery until disease recurrence or death

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Torgunrud Kristensen, PhD

CONTACT

[email protected]

+47 22 78 19 45

Kjersti Flatmark, MD PhD

CONTACT

[email protected]

+47 22 93 40 00

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Acronym: PSM

Important dates

Study start
2009
Primary completion
2022
Study completion
2027
First posted
Feb 27, 2014
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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