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Investigating cancer treatment effects during pregnancy on mothers and children

Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

Observational University Hospital, Gasthuisberg · NCT00330447

This study looks at how cancer treatments during pregnancy affect mothers and their children in the long run.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages18 Years and up
SexFemale
SponsorUniversity Hospital, Gasthuisberg Academic / other
Drugs / interventionsradiation, chemotherapy
Locations33 sites (Camden, New Jersey and 32 other locations)
Trial IDNCT00330447 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the outcomes for mothers diagnosed with cancer during pregnancy and the long-term effects on their children who were exposed to cancer treatments such as chemotherapy and radiotherapy. It includes collecting maternal blood samples, umbilical cord blood, and biopsies to evaluate fetal growth and maternal health. Additionally, the study will measure maternal and paternal anxiety related to the cancer diagnosis and conduct long-term follow-ups on the children to monitor their neurological and cardiological development. The study is structured in two parts, focusing on both maternal outcomes and child development.

Who should consider this trial

Good fit: Ideal candidates include premenopausal women over 18 years old with histologically proven cancer diagnosed during pregnancy or within five years post-pregnancy.

Not a fit: Patients with significant mental disabilities that prevent informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safety and outcomes of cancer treatments during pregnancy, potentially guiding future clinical practices.

How similar studies have performed: While there have been studies on cancer treatment during pregnancy, this specific approach focusing on long-term outcomes for both mothers and children is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Patients do not need to participate in both; however, preferentially both study parts should be performed.

\*\*\*\*\*\*\*\*\*\*\*\*\*\*Part I: Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\*\*\*\*\*

Patients must meet the following inclusion criteria:

* 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 Criteria:

* Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

\*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\*

Inclusion Criteria:

\- 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 Criteria:

* Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Where this trial is running

Camden, New Jersey and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CancerPregnancypregnancyin uterochemotherapyradiotherapycanceroffspring
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.