Maternal Cancer Diagnosis and Treatment During Pregnancy:a Database for Maternal, Fetal, and Neonatal Outcomes (CANCRPREGREG)
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|ClinicalTrials.gov Identifier: NCT02749474|
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : March 5, 2019
|Condition or disease|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||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|
|Study Start Date :||July 2003|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
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.
- 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
- Congenital Malformations [ Time Frame: From birth to 5 years of age ]Incidence of children in registry diagnosed with birth defects
- 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.
- 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.
- 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.
- Maternal Survival [ Time Frame: Yearly 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 age [ Time Frame: 18 months of age to 3 years ]Score on Bayley Scales of Infant Development - Second Edition (BSID-III)
- 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)
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749474
|Contact: Elyce H Cardonick, MDemail@example.com|
|Contact: Harry Mazurek|
|United States, New Jersey|
|Cooper University Hospital||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Elyce H Cardonick, MD 856-342-2065 firstname.lastname@example.org|
|Contact: Gunda Simpkins, RN 8569687547 email@example.com|
|Principal Investigator:||Elyce H Cardonick, MD||Cooper Health System|