An observational study in Pregnancy, Cancer, Cancer in Pregnancy, Gestational Breast Cancer, Pregnancy Related, sponsored by The Cooper Health System. Recruiting at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by The Cooper Health System · Observational
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.
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 non-pregnant 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 during childhood and adult development. Some children in this cohort have been followed up to 28 years of age.
The majority of fetal organ development 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, 35 were exposed to chemotherapy. 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. Together Dr Cardonick and Dr Amant have evaluated children up to age 9 who were exposed to chemotherapy before birth. Reassuringly chemotherapy did not impact neurologic development, or heart performance up to age 9 years. A current study is looking at children at age 12. Studies are looking at children after exposure to both chemotherapy or radiation or cancer surgery during pregnancy. Currently Dr Cardonick is in contact with young adults in the study who are at least 18 years of age who are participating in a self-assessment tool of their physical, mental and social health. Such long follow up is what helps newly diagnosed pregnant women make informed decisions about cancer treatment during pregnancy.
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 to follow the growth and development of the child. Participants do not have to collect their own records. All information is kept confidential. Oncologic follow up on the women is also requested yearly.
The Cooper Health System is the lead sponsor of 67 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cohort of pregnant women diagnosed with any type of cancer.
Exclusion Criteria:
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.
Neonatal Developmental Quotient
Pediatrician asked to assess developmental age compared to chronological age, ie developmental quotient
Time frame: Yearly from 3 months to 12 years of age
Congenital Malformations
Incidence of children in registry diagnosed with birth defects after a pregnancy complicated by a cancer diagnosis.
Time frame: From birth to 5 years of age
Mass Liquid Chromotography will be used to measure intact Taxane, Adriamycin and Cyclophosphamide chemotherapy andthe corresponding metabolites in neonatal meconium by mass liquid chromatography.
On day one of life patients who received chemotherapy during pregnancy for breast cancer can collect and submit up to 3 meconium specimens from their newborn and return in provided self addressed package with ice and all supplies provided.
Time frame: One to three specimens collected on day one of life.
Child's height percentage for age at yearly pediatric visit
Pediatrician surveyed yearly for child's height percentage for current age based on population normals.
Time frame: Yearly until 18 years of age.
Child's weight percentage for age at yearly pediatric visit
Pediatrician surveyed yearly for child's weight percentage for current age based on population normals.
Time frame: Yearly until 18 years of age.
Maternal Survival
Oncologist surveyed yearly for maternal cancer free and overall survival
Time frame: Yearly after end of pregnancy up to 10 years.
Developmental performance up to 3 years of age
Score on Bayley Scales of Infant Development - Second Edition (BSID-III)
Time frame: 18 months of age to 3 years
Developmental performance 4-7 years of age
The Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R)
Time frame: Once when child is available between ages 4 to 7
Developmental performance 8 years of age and above
The Wechsler Intelligence Scale for Children, Third Edition (WISC III)
Time frame: Once when child is available after age 8
Behavioral Development at ages 1.5-5 years, 6-12 years, 17+ years
Parents complete the Complete Behavioral Checklist according to child's age. At age 17+ the young adult completes it themselves.
Time frame: Three times during the child's life according to ages listed above.
Incidence of medical conditions in children of women with cancer during pregnancy.
Pediatricians are asked to report any medical conditions the child is being treated for.
Time frame: Yearly until 18 years of age.
Plan to share: Undecided
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