RecruitingObservational

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

NCT ID: NCT00330447Sponsor: University Hospital, GasthuisbergLast updated: 2024-03-06

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.

Arms & interventions

Outcome measures

Primary

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

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: Yes

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

Study locations (1)

Cooper University Hospital (2015-ongoing)

Camden, New Jersey, 08103

Recruiting

Elyce Cardonick, MD · Contact

References

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