Observational Study: Cancer Treatment During Pregnancy

This observational study is looking at the effects of cancer and its treatments on mothers and their children when cancer occurs during pregnancy. Researchers want to understand how mothers diagnosed with cancer during pregnancy fare over time. They also want to see if children exposed to cancer treatments like chemotherapy, radiation therapy, or targeted therapy before birth develop normally, especially regarding their brain and heart health. The study aims to enroll 5000 women aged 18 and older who have a histologically proven (confirmed by looking at tissue under a microscope) cancer diagnosis during pregnancy or within five years after. This study does not involve new treatments; it observes what happens to mothers and children in these situations.

Study design
This is an observational study aiming to enroll 5000 participants. It is not testing a new treatment but rather observing outcomes for mothers and children.
What's involved
If you are a mother, you may be asked to provide a blood sample, and umbilical cord blood and placental biopsies may be collected. You might also complete questionnaires. If your child is part of the study, they will have regular check-ups until age 18, and then cardiologic assessments and questionnaires every five years until age 43. MRI sessions are optional at certain ages.
Compensation
Not stated in the trial record.
Follow-up
Mothers will be followed up at an anticipated time. Children will have regular check-ups until age 18, and then follow-up with cardiologic assessments and questionnaires every five years until age 43.

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NCT00330447

Effects of Oncological Treatment During Pregnancy on Mother and Child

Recruiting
Not specifiedAges 18+Observational
University Hospital, Gasthuisberg
~5,000 participants
Updated 2024-03-06 on ClinicalTrials.gov

At a glance

Recruiting sites
22 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Follow-up of the mothers diagnosed with cancer during pregnancy
Measured over anticipated
+1 more outcome measured
Cancer
Pregnancy
33 sites across 20 states
Italy5
Greece4
Poland3
Russia3
Belgium2
Czechia2
New Jersey1
Argentina1
  • Amant Frederic, MD PhD · PRINCIPAL_INVESTIGATOR · KULeuven, Belgium

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Eligibility criteria

Inclusion

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).

Exclusion

Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
  • Follow-up of the mothers diagnosed with cancer during pregnancyanticipated

    treatment during pregnancy, obstetrical outcome, maternal survival

  • Follow-up of the children antenatally exposed to chemotherapy or radiotherapyanticipated

    neurologic and cardiologic outcome