NCT02073500

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2009Aug 2027

Study Start

First participant enrolled

September 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

12.9 years

First QC Date

February 17, 2014

Last Update Submit

July 21, 2021

Conditions

Pseudomyxoma PeritoneiColorectal CarcinomaOvarian CarcinomaMesothelioma

Keywords

Peritoneal carcinomatosisPeritoneal surface malignancyCytoreductive surgeryHyperthermic intraperitoneal chemotherapyCRSHIPECPrognostic biomarkerPredictive biomarker

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Time from surgery until death from any cause

    5 years

Secondary Outcomes (1)

  • Disease-free survival (DFS)

    5 years

Study Arms (1)

Observational study

Patients diagnosed with PSM undergoing CRS with HIPEC.

Other: Observational study.

Interventions

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.

Also known as: Observational study. Laboratory biomarker analysis.
Observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • age \> 18 years
  • confirmed diagnosis of peritoneal surface malignancy
  • candidate for CRS-HIPEC
  • written informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian Radium Hospital

Oslo, Norway

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30862609DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Metastatic tissue, blood specimens.

MeSH Terms

Conditions

Pseudomyxoma PeritoneiColorectal NeoplasmsOvarian NeoplasmsMesotheliomaPeritoneal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenocarcinoma, MucinousAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and SerousIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAdenomaNeoplasms, MesothelialAbdominal NeoplasmsPeritoneal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Kjersti Flatmark, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kjersti Flatmark, MD PhD

CONTACT

+47 22 93 40 00Kjersti.Flatmark@rr-research.no

Annette Torgunrud Kristensen, PhD

CONTACT

+47 22 78 19 45atj@rr-research.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 27, 2014

Study Start

September 1, 2009

Primary Completion

August 1, 2022

Study Completion (Estimated)

August 1, 2027

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

NO(1)