The RENAPE observational registry: rationale and framework of the rare peritoneal tumors French patient registry

Abstract

BackgroundRare peritoneal cancers represent complex clinical situations requiring a specific and multidisciplinary management. Because of their rarity, lack of awareness and knowledge often leads to diagnostic delays and misdiagnosis. And patients are not systematically referred to expert centers as they should be. Clinicians and researchers also face unique challenges with these rare cancers, because it is hard to conduct adequately powered, controlled trials in such small patient population. This is how an observational patient registry constitutes a key instrument for the development of epidemiological and clinical research in the field of these rare cancers. It is the appropriate tool to pool scarce data for epidemiological research and to assess the impact of diagnostic and therapeutic strategies. We aimed to provide the outlines and the framework of the RENAPE observational registry and share our experience in the establishment of a national patient registry.ResultsThe RENAPE observational registry has been launched in 2010 thanks to institutional supports. It concerns only patients with a histological diagnosis confirming a peritoneal surface malignancy. A web secured clinical database has been implemented based on data management procedures according to the principles of international recommendations and regulatory statements. A virtual tumor bank is linked in order to the conduct translational studies. Specialized working groups have been established to continuously upgrade and evolve the common clinical and histological data elements following the last classifications and clinical practices. They contribute also to standardize clinical assessment and homogenize practices.ConclusionsThe RENAPE Registry may improve awareness and understanding of the rare peritoneal tumors into the incidence, prevalence, recurrence, survival and mortality rates, as well as treatment practices thereby enabling therapeutic intervention to be evaluated and ultimately optimized.Trial registrationClinicalTrials.gov Identifier: NCT02834169

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei of appendicular and extra-appendicular origin

“…Data were collected from the French National Network of Peritoneal Surface Malignancies (RENAPE) database, which includes patients treated for PMP at 20 centres of expertise in peritoneal surface malignancy between 1994 and 2016. All patients with pathologically confirmed PMP treated with CCRS and HIPEC were selected for this study.…”

“…For each patient, the data were extracted from the RENAPE database, which complies with applicable local regulations and with the ethical principles (Declaration of Helsinki, Fortaleza 2013) relating to data processing, files, and personal freedom and privacy.…”

MESOTIP: Phase II multicenter randomized trial evaluating the association of PIPAC and systemic chemotherapy vs. systemic chemotherapy alone as 1st-line treatment of malignant peritoneal mesothelioma

“…A recent publication has already shown that 90 days morbidity is better evaluated with CTCAE v5.0 than with the Clavien Dindo classification in patients who underwent CRS and hyperthermic intraperitoneal chemotherapy [29]. As PIPAC is a drug delivery method, it can be inferred that this classification is also superior to the Clavien Dindo classification [28]. However, the latter will also be present in the CRF for comparative purposes.…”

Treading the beaten path with old and new obstacles: a report from the Indian HIPEC registry

“…The functioning of the registry has been described elsewhere [8]. Briefly, the registry enrolls patients with PM who have undergone palliative or potentially curative surgical treatment for PM.…”

“…Surgeons/ centres from neighbouring countries are also enrolled in the registry. The importance of such a registry [7] has been demonstrated by the scientific contributions made by two national registries: the RENAPE [8] and BIG-RENAPE [9] in France and the Netherlands cancer registry [10] in the Netherlands.…”