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Spots Global Cancer Trial Database for International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

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Trial Identification

Brief Title: International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Official Title: Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

Study ID: NCT03210298

Interventions

PIPAC

Study Description

Brief Summary: Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

Detailed Description: All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned. The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia. The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board. An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

Eligibility

Minimum Age: 10 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Roffo Cancer Institute, Buenos Aires, , Argentina

Peter MacCallum Cancer Centre, Melbourne, , Australia

SALK - Salzburger Landeskliniken, Salzburg, , Austria

University Hospital Gent (UZ Gent), Gent, , Belgium

University Hospital Odense, Odense, , Denmark

Centre Hospitalier Universitaire, Grenoble, , France

Centre Hospitalier Universitaire, Lille, , France

Hospices civils de Lyon, Lyon, , France

Centre du Cancer, Montpellier, , France

University Hospital Tübingen, Tübingen, , Germany

IRCC Torino Candiolo, Turin, , Italy

F. Łukaszczyk Oncology Centre, Bydgoszcz, , Poland

Gersten Institute for Cancer Research, Moscow, , Russian Federation

National University Hospital, Singapore, , Singapore

Hospital de Pilar, Barcelona, , Spain

University Hospital Lausanne CHUV, Lausanne, , Switzerland

Contact Details

Name: Philipp Horvath, MD

Affiliation: University Hospital Tuebingen

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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