Effects of Oncological Treatment During Pregnancy on Mother and Child

Conditions

Cancer, Pregnancy

Keywords

pregnancy, in utero, chemotherapy, radiotherapy, cancer, offspring, neonatal, long term, follow up, cancer during pregnancy, chemotherapy and radiotherapy during pregnancy, long term follow up of children

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.

Van Assche IA, Van Calsteren K, Huis In 't Veld EA, van Gerwen M, Heylen L, LeJeune CL, Cardonick E, Halaska MJ, Fruscio R, Fumagalli M, van Dijk-Lokkart EM, Lemiere J, van Grotel M, Lagae L, van den Heuvel-Eibrink MM, Amant F.

2024-11-113 citations

10.1016/j.eclinm.2024.102922

Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy.

Vandenbroucke T, Verheecke M, van Gerwen M, Van Calsteren K, Halaska MJ, Fumagalli M, Fruscio R, Gandhi A, Veening M, Lagae L, Ottevanger PB, Voigt JU, de Haan J, Gziri MM, Maggen C, Mertens L, Naulaers G, Claes L, Amant F, International Network on Cancer, Infertility and Pregnancy (INCIP).

2020-08-2544 citations

10.1016/j.ejca.2020.07.004

Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients.

de Haan J, Verheecke M, Van Calsteren K, Van Calster B, Shmakov RG, Mhallem Gziri M, Halaska MJ, Fruscio R, Lok CAR, Boere IA, Zola P, Ottevanger PB, de Groot CJM, Peccatori FA, Dahl Steffensen K, Cardonick EH, Polushkina E, Rob L, Ceppi L, Sukhikh GT, Han SN, Amant F, International Network on Cancer and Infertility Pregnancy (INCIP).

2018-01-26254 citations

10.1016/s1470-2045(18)30059-7

Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy

Frédéric Amant, Tineke Vandenbroucke, Magali Verheecke, Monica Fumagalli, M Halaška et al. (20 authors)

New England Journal of Medicine2015-09-28361 citations

10.1056/nejmoa1508913

Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study.

Amant F, Van Calsteren K, Halaska MJ, Gziri MM, Hui W, Lagae L, Willemsen MA, Kapusta L, Van Calster B, Wouters H, Heyns L, Han SN, Tomek V, Mertens L, Ottevanger PB.

2012-02-10177 citations

10.1016/s1470-2045(11)70363-1

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

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

Countries

Argentina, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Tunisia, Turkey (Türkiye), Ukraine, United States

Contacts

Primary ContactAyaka Wakatsuki

ayaka.wakatsuki@uzleuven.be+32 16 34 41 69

Backup ContactKristel Van Calsteren, MD PhD

kristel.vancalsteren@uzleuven.be+32-16-346192

Outcome results