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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
Sponsor:
Information provided by (Responsible Party):
Elyce Cardonick, The Cooper Health System

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.

Condition or disease
Pregnancy,Neoplastic Complications

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Congenital Malformations [ Time Frame: From birth to 5 years of age ]
    Incidence of children in registry diagnosed with birth defects


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. Maternal Survival [ Time Frame: Yearly after end of pregnancy up to 10 years. ]
    Oncologist surveyed yearly for maternal cancer free and overall survival

  5. 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)

  6. 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)

  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)

  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cohort of pregnant women diagnosed with any type of cancer.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Elyce H Cardonick, MD 8563422491 cardonick-elyce@cooperhealth.edu
Contact: Harry Mazurek

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Elyce H Cardonick, MD    856-342-2065    cardonick-elyce@cooperhealth.edu   
Contact: Gunda Simpkins, RN    8569687547    simpkins-gunda@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System
Investigators
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Principal Investigator: Elyce H Cardonick, MD Cooper Health System

Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Elyce Cardonick, Associate Dean for Research, The Cooper Health System
ClinicalTrials.gov Identifier: NCT02749474     History of Changes
Other Study ID Numbers: Cooper 15-028
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pregnancy Complications, Neoplastic
Neoplasms
Pregnancy Complications