Maternal Cancer Diagnosis and Treatment During Pregnancy:a Database for Maternal, Fetal, and Neonatal Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorThe Cooper Health System
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Women diagnosed with cancer more than 6 months after the end of a pregnancy.
Trial population
Cohort of pregnant women diagnosed with any type of cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Pregnant women diagnosed with cancer
Trial outcomes
Primary outcomes
1
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 ageSecondary outcomes
1
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 ageOther outcomes
1
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.2
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.3
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.4
Maternal Survival
Oncologist surveyed yearly for maternal cancer free and overall survival
Time frame
Yearly after end of pregnancy up to 10 years.Sponsors and contacts
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Source ClinicalTrials.gov