Investigating cancer treatment effects during pregnancy on mothers and children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cooper University Hospital (2015-ongoing)
  Camden, New Jersey, United States Recruiting
• UCL Brussels (2013-ongoing)
  Brussels, Belgium Recruiting
• UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
  Leuven, Belgium Recruiting
• University Hospital Ostrava (2018-ongoing)
  Ostrava, Czechia Recruiting
• 3rd medical faculty of Charles University (2010-ongoing)
  Prague, Czechia Recruiting
• Copenhagen University Hospital (2015-ongoing)
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Amant Frederic, MD PhD — KULeuven, Belgium
• Study coordinator: Ayaka Wakatsuki
• Email: ayaka.wakatsuki@uzleuven.be
• Phone: +32 16 34 41 69

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.