RecruitingNCT00330447
Effects of Oncological Treatment During Pregnancy on Mother and Child
Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Sponsor
University Hospital, Gasthuisberg
Enrollment
5,000 participants
Start Date
Aug 1, 2005
Study Type
OBSERVATIONAL
Conditions
Summary
The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or 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).
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria7
- Patients do not need to participate in both; however, preferentially both study parts should be performed.
- \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part I: Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\*\*\*\*\*
- Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy)
- \> 18 years of age, premenopausal
- Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
- Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II).
- \- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.
Exclusion Criteria3
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
- \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\*
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Locations(33)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT00330447
Related Trials
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
NCT074245475 locations
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
NCT053181961 location
Placental Imaging Techniques
NCT068613091 location
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
NCT055881411 location
Small Bowel Capsule Endoscopy in Lynch Syndrome
NCT074726861 location