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

August 3, 2020 updated by: Elyce Cardonick, The Cooper Health System

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

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.

Study Overview

Status

Recruiting

Conditions

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 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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Harry Mazurek

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Cohort of pregnant women diagnosed with any type of cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pregnant women diagnosed with cancer
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Developmental Quotient
Time Frame: Yearly from 3 months to 12 years of age
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
Time Frame: From birth to 5 years of age
Incidence of children in registry diagnosed with birth defects
From birth to 5 years of age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of defects in amelogenesis, or tooth eruption after chemotherapy exposure in utero.
Time Frame: Yearly assessment after age 3 up to 12 years of age.
Child's pediatric dentist is contacted for incidence of enamel defects or abnormal eruption of teeth.
Yearly assessment after age 3 up to 12 years of age.
Child's height percentage for age at yearly pediatric visit
Time Frame: Yearly until 18 years of age.
Pediatrician surveyed yearly for child's height percentage for current age based on population normals.
Yearly until 18 years of age.
Child's weight percentage for age at yearly pediatric visit
Time Frame: Yearly until 18 years of age.
Pediatrician surveyed yearly for child's weight percentage for current age based on population normals.
Yearly until 18 years of age.
Maternal Survival
Time Frame: Yearly after end of pregnancy up to 10 years.
Oncologist surveyed yearly for maternal cancer free and overall survival
Yearly after end of pregnancy up to 10 years.
Developmental performance up to 3 years of age
Time Frame: 18 months of age to 3 years
Score on Bayley Scales of Infant Development - Second Edition (BSID-III)
18 months of age to 3 years
Developmental performance 4-7 years of age
Time Frame: Once when child is available between ages 4 to 7
The Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R)
Once when child is available between ages 4 to 7
Developmental performance 8 years of age and above
Time Frame: Once when child is available after age 8
The Wechsler Intelligence Scale for Children, Third Edition (WISC III)
Once when child is available after age 8
Mass Liquid Chromotography will be used to measure intact Taxane chemotherapy and taxane metabolites in neonatal meconium by mass liquid chromatography.
Time Frame: One to three specimens collected on day one of life.
On day one of life patients who received chemotherapy during pregnancy 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.
One to three specimens collected on day one of life.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Investigators

  • Principal Investigator: Elyce H Cardonick, MD, Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cooper 15-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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