Maternal Cancer Diagnosis and Treatment During Pregnancy:a Database for Maternal, Fetal, and Neonatal Outcomes

Study Overview
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Brief Summary
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The objective of this study is to follow the treatment options offered to pregnant women diagnosed with cancer and study the impact that their treatment or delay of treatment has on their own health and that of their children.

Detailed Description
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Approximately 1:1000 pregnancies are complicated by cancer. Breast cancer is the most common type diagnosed during pregnancy. Termination of pregnancy has not demonstrated an improvement in survival. Results of an international collaborative study reported similar overall survival for patients diagnosed with breast cancer in pregnancy compared to nonpregnant patients. The consensus medical opinion supports the option to start treatment with continuation of the pregnancy. The purpose of this Cancer and Pregnancy Registry study is to prospectively follow the women diagnosed with cancer during pregnancy-collecting information about the method of diagnosis, treatment options and maternal and neonatal outcomes at delivery and yearly at follow up. The majority of fetal organogenesis is completed by 12 weeks of pregnancy, consistent with the literature showing no increased malformation rate for chemotherapy use after the first trimester of pregnancy. The central nervous system continues to develop throughout gestation and after birth. Whether chemotherapy given after the first trimester affects central nervous system maturity and results in developmental delays requires further study. The first authors to provide detailed follow up on children exposed to chemotherapy in utero were Aviles and Niz in 1988. At that time 17 children ranging in age from 4-22 years born to mothers with acute leukemia who received chemotherapy during pregnancy were examined for physical health, growth and development. Each child demonstrated normal growth and development, school performance, intelligence testing, neurological examination, and hematologic evaluation including bone marrow biopsies. This study was expanded twice. First in 1991, to 43 children ranging in age from 3 to 19 years, also after exposure in utero to chemotherapy for maternal hematologic malignancies. All children were normal physically and neurologically. School performances and standardized intelligence testing were not significantly different from controls (unrelated matched children and unexposed siblings). The same authors expanded their study again to a final report of 84 children in 2001, confirming their previous reports that chemotherapy at full doses for an aggressive hematological malignancy can be safely administered. Standardized testing on children exposed to chemotherapy was not repeated for 11 years. Drs. Amant, et al reported developmental outcomes of 70 children in Europe exposed to cancer treatment in utero. The children with developmental delays were concentrated in the group delivered preterm. In this study there was not a control group of unexposed children. Cardonick also performed developmental testing on 57 children of women diagnosed with cancer during pregnancy. Ninety-five percent of children scored within normal limits on cognitive assessments; 71% and 79% of children demonstrated at or above age equivalency in mathematics and reading scores respectively. Tooth formation of the primary teeth begins at 11 to 14 weeks of fetal life and is completed postnatally. The enamel of the primary teeth begins to develop at 10 weeks and gradually continues to develop throughout pregnancy; enamel development on the permanent teeth starts in week 28 and begins to mineralize at the time of birth. It is known that both tetracycline and antiepileptic medications use during pregnancy can affect tooth development. For example, prenatal exposure tetracycline induces discoloration of deciduous teeth, while exposure to antiepileptic drugs increases the risk of enamel opacities and hypoplasia. Enamel hypoplasia increases susceptibility for primary dental caries due to an increased risk for bacterial colonization. Peretz et al in 2003 reported the dental examination of 2 children exposed to Doxorubicin+/-Cyclophosphamide during the third trimester for breast cancer. Both children at 18 and 30 months of age had normal primary teeth. Three women in the Cancer and Pregnancy Registry have reported dental issues in their young children including under developed primary teeth and early childhood caries. The effect of in utero exposure to chemotherapy on amelogenesis requires further study. Women diagnosed with cancer of any type during pregnancy can enroll voluntarily in the Cancer and Pregnancy Registry. Signed medical release forms allow the investigator to review cancer diagnostic studies and treatment course. Records are requested yearly from the treating pediatrician and dentist to follow the growth and development of the child. All information is kept confidential. Oncologic follow up on the women is also requested yearly.

Official Title
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Maternal Cancer Diagnosis and Treatment During Pregnancy:a Registry for Maternal, Fetal, and Neonatal Outcomes With Longitudinal Follow up of Child Development and Maternal Psychological Well Being

Conditions
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Pregnancy,Neoplastic Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any pregnant woman diagnosed with cancer within 6 weeks before her last menstrual period or 6 months after her end of pregnancy either by delivery or miscarriage. Exclusion Criteria: Women diagnosed with cancer more than 6 months after the end of a pregnancy.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women diagnosed with cancer<br>Any pregnant woman diagnosed with any cancer within 6 weeks prior to their last menstrual period, or up to 6 months after the end of their pregnancy can be enrolled. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Developmental Quotient | Pediatrician asked to assess developmental age compared to chronological age, ie developmental quotient | Yearly from 3 months to 12 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Congenital Malformations | Incidence of children in registry diagnosed with birth defects | From birth to 5 years of age |