Reference SummaryHaseman JK, Toxicol Pathol 1984;12(2):126-35

Title

 Use of historical control data in carcinogenicity studies in rodents.

Authors

 Haseman JK; Huff J; Boorman GA

Journal

 Toxicol Pathol

Volume

 12

Issue

 2

Year

 1984

Pages

 126-35

Abstract

 This paper considers the use of historical control data in the evaluation of tumor incidences from carcinogenicity studies in rodents. Although the most appropriate control group for interpretative purposes is always the concurrent control, there are instances in which the use of historical control information can aid an investigator in the overall evaluation of tumor incidence data. One example is rare tumors; another is a tumor that shows a marginally significant result relative to concurrent controls. However, before historical control data can be used in a formal testing framework, a number of important issues must first be considered. The nomenclature conventions and diagnostic criteria for each study should be identical to insure unambiguous identification of all relevant tumors in the historical control database. Criteria should be established that will aid in determining whether a particular study should be included in the database. This will assure a homogeneous set of studies upon which to base statistical comparisons. Since study-to-study variability in tumor rates may exceed what would be expected by chance alone, these sources of variability should be identified and controlled. Finally, statistical procedures should be employed that adjust for extra-binomial variability. This paper also summarizes tumor incidence data from untreated Fischer 344 rats and B6C3F1 mice in the National Toxicology Program (NTP) historical control database. All studies in the database are of two years duration, and all neoplasms occurring with a frequency of 0.5% or more are reported.

Links

 J:70921 – MGI References
11478313 – National Library of Medicine/PubMed

Strain Notes

Strain Note
(C57BL/6 x C3H)F1 Controls from NCI/NTP studies from multiple laboratories were analyzed.

Models
Strain Model Name Treatment Agent(s) Organ Affected Frequency Model Details
(C57BL/6 x C3H)F1 Adipose tissue lipoma Adipose tissue

0
(C57BL/6 x C3H)F1 Adrenal gland - Cortex adenoma Adrenal gland - Cortex

0.3 - 2.4
(C57BL/6 x C3H)F1 Adrenal gland - Cortex carcinoma Adrenal gland - Cortex

0.04 - 0.1
(C57BL/6 x C3H)F1 Adrenal gland - Medulla pheochromocytoma Adrenal gland - Medulla

0.7 - 1.25
(C57BL/6 x C3H)F1 Adrenal gland - Medulla pheochromocytoma - malignant Adrenal gland - Medulla

0 - 0.1
(C57BL/6 x C3H)F1 Blood vessel hemangioma Blood vessel

1.5 - 1.6
(C57BL/6 x C3H)F1 Blood vessel hemangiosarcoma Blood vessel

1.9 - 2.7
(C57BL/6 x C3H)F1 Blood vessel tumor Blood vessel

0 - 20
(C57BL/6 x C3H)F1 Bone osteosarcoma Bone

0.1 - 0.6
(C57BL/6 x C3H)F1 CNS - Brain - Astrocyte astrocytoma CNS - Brain - Astrocyte

0
(C57BL/6 x C3H)F1 Clitoral gland adenoma Clitoral gland

0
(C57BL/6 x C3H)F1 Clitoral gland carcinoma Clitoral gland

0
(C57BL/6 x C3H)F1 Connective tissue - Fibroblast tumor Connective tissue - Fibroblast

0 - 23
(C57BL/6 x C3H)F1 Eye - Harderian gland adenoma Eye - Harderian gland

1.3 - 2.1
(C57BL/6 x C3H)F1 Eye - Harderian gland carcinoma Eye - Harderian gland

0.04 - 0.1
(C57BL/6 x C3H)F1 Forestomach squamous cell carcinoma Forestomach

0 - 0.1
(C57BL/6 x C3H)F1 Forestomach squamous cell papilloma Forestomach

0.3 - 0.5
(C57BL/6 x C3H)F1 Intestine - Small Intestine adenocarcinoma Intestine - Small Intestine

0.1 - 0.7
(C57BL/6 x C3H)F1 Leukocyte leukemia Leukocyte

0.7 - 2.1
(C57BL/6 x C3H)F1 Leukocyte lymphoma Leukocyte

2 - 62
(C57BL/6 x C3H)F1 Leukocyte tumor - malignant Leukocyte

12.7 - 27.2
(C57BL/6 x C3H)F1 Liver adenoma Liver

0 - 22
(C57BL/6 x C3H)F1 Liver carcinoma Liver

0 - 36
(C57BL/6 x C3H)F1 Liver neoplasm Liver

7.9 - 31.1
(C57BL/6 x C3H)F1 Liver neoplasm - benign Liver

4.0 - 10.3
(C57BL/6 x C3H)F1 Lung adenoma Lung

5.5 - 12.1
(C57BL/6 x C3H)F1 Lung carcinoma Lung

2.0 - 5.1
(C57BL/6 x C3H)F1 Lung tumor Lung

0 - 34
(C57BL/6 x C3H)F1 Mammary gland adenocarcinoma Mammary gland

0 - 1.6
(C57BL/6 x C3H)F1 Mammary gland fibroadenoma Mammary gland

0 - 0.3
(C57BL/6 x C3H)F1 Mesodermal cell/mesoblast sarcoma Uterus - Endometrium - Stroma

0.6
(C57BL/6 x C3H)F1 Mesodermal cell/mesoblast sarcoma - unclassified Mesodermal cell/mesoblast

0.7 - 1.7
(C57BL/6 x C3H)F1 Mesothelium mesothelioma Testis - Tunica vaginalis

0
(C57BL/6 x C3H)F1 Mesothelium mesothelioma Mesothelium

0 - 0.1
(C57BL/6 x C3H)F1 Muscle - Striated - Skeletal rhabdomyosarcoma Muscle - Striated - Skeletal

0.1 - 0.5
(C57BL/6 x C3H)F1 Ovary - Granulosa cell neoplasm Ovary - Granulosa cell

0.1
(C57BL/6 x C3H)F1 Ovary adenoma - tubular Ovary

0.9
(C57BL/6 x C3H)F1 PNS - Schwann cell neurofibroma PNS - Schwann cell

0.04 - 1.2
(C57BL/6 x C3H)F1 PNS - Schwann cell neurofibrosarcoma PNS - Schwann cell

0.8 - 2.8
(C57BL/6 x C3H)F1 Pancreas - Islet of Langerhans adenoma Pancreas - Islet of Langerhans

0.4
(C57BL/6 x C3H)F1 Pancreas - Islet of Langerhans carcinoma Pancreas - Islet of Langerhans

0 - 0.1
(C57BL/6 x C3H)F1 Pituitary gland adenoma Pituitary gland

0 - 30
(C57BL/6 x C3H)F1 Pituitary gland carcinoma Pituitary gland

0.05 - 0.4
(C57BL/6 x C3H)F1 Preputial gland (male) adenoma Preputial gland (male)

0.1
(C57BL/6 x C3H)F1 Preputial gland (male) carcinoma Preputial gland (male)

0
(C57BL/6 x C3H)F1 Prostate gland adenoma Prostate gland

0
(C57BL/6 x C3H)F1 Skin - Epidermis - Basal cell neoplasm Skin - Epidermis - Basal cell

0.1 - 0.2
(C57BL/6 x C3H)F1 Skin keratoacanthoma Skin

0
(C57BL/6 x C3H)F1 Skin squamous cell carcinoma Skin

0.2
(C57BL/6 x C3H)F1 Skin squamous cell papilloma Skin

0.1 - 0.2
(C57BL/6 x C3H)F1 Testis - Leydig cell (Interstitial cell) tumor Testis - Leydig cell (Interstitial cell)

0.3
(C57BL/6 x C3H)F1 Thyroid gland - Follicular cell adenoma Thyroid gland - Follicular cell

1.0 - 1.8
(C57BL/6 x C3H)F1 Thyroid gland - Follicular cell carcinoma Thyroid gland - Follicular cell

0.2 - 0.3
(C57BL/6 x C3H)F1 Thyroid gland - Medulla - C cell adenoma Thyroid gland - Medulla - C cell

0 - 0.1
(C57BL/6 x C3H)F1 Thyroid gland - Medulla - C cell carcinoma Thyroid gland - Medulla - C cell

0
(C57BL/6 x C3H)F1 Uterus - Endometrium - Stroma polyp Uterus - Endometrium - Stroma

0.9