Neonatal CMV-Ganciclovir Follow-up Study
Condition: Cytomegalovirus Infections
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Observational

Summary: 
      The purpose of this study is to document the developments associated with puberty and
      determine if any of the children who previously participated in another research study have
      been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group
      (CASG) protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic
      Congenital Cytomegalovirus Infections." One of the medications used in this study to treat
      cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development
      of gonads (ovaries in females and testes in males) when administered to animals. Children,
      9-14 years old, who participated in the previous research study, will participate in this
      study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following
      procedures performed: a complete physical examination, a single blood sample collected, an
      x-ray of the left wrist.
    

Detailed description: 
      Ganciclovir has been shown to be carcinogenic, teratogenic, and gonadal toxic in animal
      models. Mice treated with ganciclovir experienced an increase in the incidence of tumors of
      the preputial gland (males), harderian gland (males), forestomach (males and females),
      ovaries (females), uterus (females), mammary gland (females), clitoral gland (females),
      vagina (females), and liver (females). While the preputial and clitoral glands, forestomach,
      and harderian glands of mice do not have human counterparts, ganciclovir is considered a
      potential carcinogen in humans. Animal data indicate that administration of ganciclovir
      causes inhibition of spermatogenesis and subsequent infertility, possibly due to inhibition
      of rapidly dividing cell populations including spermatogonia. In the animal models, these
      effects were reversible at lower doses and irreversible at higher doses. In both male and
      female mice, ganciclovir has been shown to cause decreased fertility. Gonadal toxicity in
      rats, mice, and dogs included testicular atrophy in males and, more variable, ovarian atrophy
      in females. There are no data in humans that demonstrate these effects following treatment
      with ganciclovir. This study seeks to formally establish the overall sexual development,
      cancer incidence, and pubertal status of those study subjects who previously received six
      weeks of ganciclovir as they now approach puberty. The original study was performed from 1986
      to 1991, and therefore subjects who were enrolled are now nine to fourteen years of age.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children of both genders that previously enrolled in "Evaluation of Ganciclovir (DHPG) for
        the Treatment of Symptomatice Congenital Cytomegalovirus Infections."
      
Keywords: CMV, cytomegalovirus, children, ganciclovir