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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02749474
Acronym
CANCRPREGREG
Enrollment
400
Registered
2016-04-25
Start date
2003-07-31
Completion date
2025-07-31
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Cancer, Cancer in Pregnancy, Gestational Breast Cancer, Pregnancy Related

Brief summary

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

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.

Interventions

None listed

Sponsors

The Cooper Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Developmental QuotientYearly from 3 months to 12 years of agePediatrician asked to assess developmental age compared to chronological age, ie developmental quotient

Secondary

MeasureTime frameDescription
Congenital MalformationsFrom birth to 5 years of ageIncidence of children in registry diagnosed with birth defects after a pregnancy complicated by a cancer diagnosis.

Other

MeasureTime frameDescription
Child's weight percentage for age at yearly pediatric visitYearly until 18 years of age.Pediatrician surveyed yearly for child's weight percentage for current age based on population normals.
Maternal SurvivalYearly after end of pregnancy up to 10 years.Oncologist surveyed yearly for maternal cancer free and overall survival
Developmental performance up to 3 years of age18 months of age to 3 yearsScore on Bayley Scales of Infant Development - Second Edition (BSID-III)
Mass Liquid Chromotography will be used to measure intact Taxane, Adriamycin and Cyclophosphamide chemotherapy andthe corresponding metabolites in neonatal meconium by mass liquid chromatography.One to three specimens collected on day one of life.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.
Developmental performance 8 years of age and aboveOnce when child is available after age 8The Wechsler Intelligence Scale for Children, Third Edition (WISC III)
Behavioral Development at ages 1.5-5 years, 6-12 years, 17+ yearsThree times during the child's life according to ages listed above.Parents complete the Complete Behavioral Checklist according to child's age. At age 17+ the young adult completes it themselves.
Incidence of medical conditions in children of women with cancer during pregnancy.Yearly until 18 years of age.Pediatricians are asked to report any medical conditions the child is being treated for.
Developmental performance 4-7 years of ageOnce when child is available between ages 4 to 7The Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R)
Child's height percentage for age at yearly pediatric visitYearly until 18 years of age.Pediatrician surveyed yearly for child's height percentage for current age based on population normals.

Countries

United States

Contacts

Primary ContactElyce H Cardonick, MD
cardonick-elyce@cooperhealth.edu856342 2065
Backup ContactHarry Mazurek

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026