Effects of Oncological Treatment During Pregnancy on Mother and Child

ConditionsCancerPregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Gasthuisberg

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

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

Trial population

Premenopausal women with a cancer diagnosis in association with cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 2 trial groups
Group A: Studygroup
Group B: Control group

Trial outcomes

Primary outcomes

1

Follow-up of the mothers diagnosed with cancer during pregnancy

treatment during pregnancy, obstetrical outcome, maternal survival

Time frame
anticipated
2

Follow-up of the children antenatally exposed to chemotherapy or radiotherapy

neurologic and cardiologic outcome

Time frame
anticipated

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Gasthuisberg

Lead sponsor

The Netherlands Cancer Institute

Collaborator

Erasmus Medical Center

Collaborator

San Gerardo Hospital

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

Charles University, Czech Republic

Collaborator