Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330447
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2006-05-25
Brief Title:
Effects of Oncological Treatment During Pregnancy on Mother and Child
Sponsor:
University Hospital Gasthuisberg
Organization:
University Hospital Gasthuisberg
Study Overview
Official Title:
Oncological Treatment During Pregnancy Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers aim to investigate the outcome overall survival of mothers who are diagnosed andor treated for cancer during pregnancy Furthermore they want to test the hypothesis that children who were exposed to cancer or cancer treatment cytotoxic drugs radiation therapy targeted therapy develop normally neurologic and cardiologic examination
Detailed Description:
Study contains several study parts protocol version 44
Part I Pregnancy delivery and maternal health Part IIA Registration study Cancer during pregnancy mother and neonate None Part IIB Effects of prenatal exposure to cancer treatment on fetal growth The association between placental pathophysiologic mechanisms histopathology and immunohistochemistry circulating maternal factors and fetal growth
From participating women a maternal blood sample will be collected during or shortly after birth Also an umbilical cord blood sample and placental and umbilical cord biopsies will be drawn
Part III Measurement of maternal and paternal anxiety and emotional needs when confronted with a cancer diagnosis during pregnancy The participants will be asked to complete questionnaires
Part II Child Long term follow up of children and adolescents in utero exposed to chemotherapy andor radiotherapy Regular check-ups of the child at the age of 6 months 18 months 3y 6y 9y 12y 15y and 18y and after the age of 18 years 5-yearly cardiologic assessment and questionnaires 23y 28y 33y 38y and 43y Optional at the ages of 9y 12y 15y and 18y MRI session
Summary part I
Prospectively the outcome of mothers diagnosed andor treated for cancer during pregnancy will be registered and investigated
Summary Part II
In a prospective trial we invite children that were exposed to cytotoxic drugs or radiotherapy in utero for a standardized neurological and cardiological examination The examinations will be done by qualified psychologists neurological and cardiological pediatricians
Part I Pregnancy delivery and maternal health Part IIA Registration study Cancer during pregnancy mother and neonate None Part IIB Effects of prenatal exposure to cancer treatment on fetal growth The association between placental pathophysiologic mechanisms histopathology and immunohistochemistry circulating maternal factors and fetal growth
From participating women a maternal blood sample will be collected during or shortly after birth Also an umbilical cord blood sample and placental and umbilical cord biopsies will be drawn
Part III Measurement of maternal and paternal anxiety and emotional needs when confronted with a cancer diagnosis during pregnancy The participants will be asked to complete questionnaires
Part II Child Long term follow up of children and adolescents in utero exposed to chemotherapy andor radiotherapy Regular check-ups of the child at the age of 6 months 18 months 3y 6y 9y 12y 15y and 18y and after the age of 18 years 5-yearly cardiologic assessment and questionnaires 23y 28y 33y 38y and 43y Optional at the ages of 9y 12y 15y and 18y MRI session
Summary part I
Prospectively the outcome of mothers diagnosed andor treated for cancer during pregnancy will be registered and investigated
Summary Part II
In a prospective trial we invite children that were exposed to cytotoxic drugs or radiotherapy in utero for a standardized neurological and cardiological examination The examinations will be done by qualified psychologists neurological and cardiological pediatricians
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None