Effects of Oncological Treatment During Pregnancy on Mother and Child

Recruiting

• Conditions: Cancer; Pregnancy

• Registration Number: NCT00330447
• Lead Sponsor: University Hospital, Gasthuisberg

Brief 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).

Detailed Description

Study contains several study parts (protocol version 4.4):

\*\*\*\*\*\*\*\*\*\*Part I. Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\* Part I.I.A. Registration study 'Cancer during pregnancy' mother and neonate None Part I.I.B. 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 I.II. 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 and/or 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 and/or 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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-04
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Follow-up of the children antenatally exposed to chemotherapy or radiotherapy	anticipated	neurologic and cardiologic outcome
Follow-up of the mothers diagnosed with cancer during pregnancy	anticipated	treatment during pregnancy, obstetrical outcome, maternal survival

Trial Locations

Locations (33)

Cooper University Hospital (2015-ongoing); 🇺🇸 Camden, New Jersey, United States

Instituto Alexander Fleming; 🇦🇷 Buenos Aires, Argentina

Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018); 🇦🇹 Graz, Austria

UCL Brussels (2013-ongoing); 🇧🇪 Brussels, Belgium

UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing); 🇧🇪 Leuven, Belgium

University Hospital Ostrava (2018-ongoing); 🇨🇿 Ostrava, Czechia

3rd medical faculty of Charles University (2010-ongoing); 🇨🇿 Prague, Czechia

Copenhagen University Hospital (2015-ongoing); 🇩🇰 Copenhagen, Denmark

Hopital Bichat-Claude-Bernard (retrospective until 2018); 🇫🇷 Paris, France

Universitätsklinik Freiburg (retrospective until 2018); 🇩🇪 Freiburg, Germany

Scroll for more (23 remaining)