Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions

Keenan, Charlotte M.; Elmore, Susan A.; Francke-Carroll, Sabine; Kemp, Ramon K.; Kerlin, Roy L.; Peddada, Shyamal D.; Pletcher, J. M.; Rinke, Matthias; Schmidt, Stephen P.; Taylor, Ian; Wolf, Douglas C.

doi:10.1177/0192623309336154

Cited by 87 publications

(85 citation statements)

References 92 publications

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“…In addition, more than 50 single data items describing the experimental conditions are collected (Morawietz et al 1992 and Table 1). These data items are compatible with the relevant variables identified by the STP working group on historical control data (Keenan et al 2009). …”

Section: Page 5 Of 43supporting

confidence: 60%

RITA—Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats

Nolte

Rittinghausen

Kellner

et al. 2011

Experimental and Toxicologic Pathology

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Historical data for Leydig cell tumors from untreated or vehicle treated rats from carcinogenicity studies collected in the RITA database are presented. Examples are given for analyses of these data for dependency on variables considered to be of possible influence on the spontaneous incidence of Leydig cell tumors.In the 7453 male rats available for analysis, only one case of a Leydig cell carcinoma was identified. The incidence of Leydig cell adenomas differed markedly between strains. High incidences of close to 100% have been found in F344 rats, while the mean incidence was 4.2% in Sprague Dawley rats and 13.7% in Wistar rats. Incidences in Wistar rats were highly variable, primarily caused by different sources of animals. Mean incidences per breeder varied from 2.8% to 39.9%.Analyses for the dependency on further parameters have been performed in Wistar rats. In breeders G and I, the Leydig cell tumor incidence decreased over the observation period and with increasing mean terminal body weight. The incidence of Leydig cell tumors increased with mean age at necropsy and was higher in studies with dietary admixture compared to gavage studies. These parameters had no effect on Leydig cell tumor incidence in breeders A and B. Animals from almost all breeders had a considerably higher mean age at necropsy when bearing a Leydig cell adenoma than animals without a Leydig cell adenoma. Studies with longitudinal trimming of the testes had a higher incidence than studies with transverse trimming.The observed dependencies and breeder differences are discussed and explanations are given.Consequences for the use of historical control data are outlined. With the retrospective Page 3 of 43 A c c e p t e d M a n u s c r i p t Nolte et al: RITA -The application of historical control data for Leydig cell tumors in rats -3 -analyses presented here we were able to confirm the published features of Leydig cell adenomas and carcinomas. This indicates that the RITA database is a valuable tool for analyses of tumors for their biological features. Furthermore, it demonstrates that the RITA database is highly beneficial for the definition of reliable historical control data for carcinogenicity studies on a scientifically solid basis.

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Section: Page 5 Of 43supporting

confidence: 60%

RITA—Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats

Nolte

Rittinghausen

Kellner

et al. 2011

Experimental and Toxicologic Pathology

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“…Historical data can be used to identify aberrant control data, to understand the relevance of increases in low-incidence findings, and/or to interpret minor differences from controls. Historical data are particularly important in the evaluation of proliferative rodent lesions (Keenan et al 2009). The working group agreed that the establishment and use of historical control data should be scientifically responsible, in that only recent studies (preferably within 5 years of primary study), performed with the genetically identical animal strain of similar age and under comparable experimental and environmental conditions, should be used for reference.…”

Section: Exacerbation Of Spontaneous/background Findingsmentioning

confidence: 99%

Characterizing “Adversity” of Pathology Findings in Nonclinical Toxicity Studies

et al. 2016

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The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports, to serve as a valuable prerequisite for future organ-or lesion-specific workshops planned by the ESTP.

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“…HCD are most useful if these factors are standardized and reported in adequate detail. 60,117 In the RITA and NACAD databases 60,116,118 and in the NTP database, data are collected by standardized procedures for tissue sampling and trimming, histopathology is assessed according to internationally harmonized nomenclature and diagnostic (INHAND) criteria, and validity of data is also confirmed by peer review. The Mouse Tumor Biology Database (http://tumor.informatics.jax.org/) and Pathbase (http:// www.pathbase.net) use standardized mouse anatomy and pathology ontologies in the Mouse Disease Information System (MoDIS) for data capture, and accept mouse pathology data and images from the Jackson Aging Center initiative, as well as from the scientific community.…”

Section: Grading Of Lesionsmentioning

confidence: 99%

Pathobiology of Aging Mice and GEM

2012

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The use of induced and spontaneous mutant mice and genetically engineered mice (and combinations thereof) to study cancers and other aging phenotypes to advance improved functional human life spans will involve studies of aging mice. Genetic background contributes to pathology phenotypes and to causes of death as well as to longevity. Increased recognition of expected phenotypes, experimental variables that influence phenotypes and research outcomes, and experimental design options and rationales can maximize the utility of genetically engineered mice (GEM) models to translational research on aging. This review aims to provide resources to enhance the design and practice of chronic and longevity studies involving GEM. C57BL6, 129, and FVB/N strains are emphasized because of their widespread use in the generation of knockout, transgenic, and conditional mutant GEM. Resources are included also for pathology of other inbred strain families, including A, AKR, BALB/c, C3H, C57L, C58, CBA, DBA, GR, NOD.scid, SAMP, and SJL/J, and non-inbred mice, including 4WC, AB6F1, Ames dwarf, B6, 129, B6C3F1, BALB/c,129, Het3, nude, SENCAR, and several Swiss stocks. Experimental strategies for long-term cross-sectional and longitudinal studies to assess causes of or contributors to death, disease burden, spectrum of pathology phenotypes, longevity, and functional healthy life spans (health spans) are compared and discussed.

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Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions

Cited by 87 publications

References 92 publications

RITA—Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats

RITA—Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats

Characterizing “Adversity” of Pathology Findings in Nonclinical Toxicity Studies

Pathobiology of Aging Mice and GEM

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