Pseudomyxoma PeritoneiPSMNCT02073500
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
An observational study of Pseudomyxoma Peritonei and Colorectal Carcinoma, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomyxoma Peritonei, Colorectal Carcinoma, Ovarian Carcinoma
- What is being tested?
- Observational study.
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Aug 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age > 18 years
- confirmed diagnosis of peritoneal surface malignancy
- candidate for CRS-HIPEC
- written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
The Norwegian Radium Hospital
Oslo
Kjersti Flatmark, MD PhD, +47 22 93 40 00, Kjersti.Flatmark@rr-research.no
Annette Torgunrud Kristensen, PhD, +47 22 78 19 45, atj@rr-research.no
About this study
Official title: Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - 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).
Read the 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.
- Being tested
- Observational study.
- Keywords
- Peritoneal carcinomatosis, Peritoneal surface malignancy, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, CRS, HIPEC, Prognostic biomarker, Predictive biomarker
- Medical subject headings
- Pseudomyxoma Peritonei, Colorectal Neoplasms, Ovarian Neoplasms, Mesothelioma, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study.Other
Also called Observational study. Laboratory biomarker analysis.
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational study | Patients diagnosed with PSM undergoing CRS with HIPEC. Receives: Other: Observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from surgery until death from any cause
Measured: 5 years
Secondary outcomes (1)
Disease-free survival (DFS)
Time from surgery until disease recurrence or death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startSep 2009
- Primary completionAug 2022 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Kjersti Flatmark, Oslo University Hospital
- Investigators
- Kjersti Flatmark, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073500
- Sponsor's protocol ID
- PSM_250913
- Acronym
- PSM
- Status last verified
- Jul 2021
- First submitted
- 17 Feb 2014
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30862609
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Peritoneal Surface Malignancies (PSM) - Characterization, Models and Treatment Strategies.
- ClinicalTrials.gov ID
- NCT02073500
- Acronym / sponsor ID
- PSM / PSM_250913
- Keywords
- Peritoneal carcinomatosis, Peritoneal surface malignancy, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, CRS, HIPEC, Prognostic biomarker, Predictive biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Sep 2009 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study | – | Other: Observational study.Patients diagnosed with PSM undergoing CRS with HIPEC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age > 18 years
- confirmed diagnosis of peritoneal surface malignancy
- candidate for CRS-HIPEC
- written informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study.Also: Observational study. Laboratory biomarker analysis.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 | Observational study |
Primary outcome
Overall survival (OS)
Time frame: 5 years
Time from surgery until death from any cause
1 secondary outcome
Disease-free survival (DFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 30862609Lund-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kjersti Flatmark, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomyxoma Peritonei and Colorectal Carcinoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kjersti Flatmark, MD PhD (+47 22 93 40 00, Kjersti.Flatmark@rr-research.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.