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Cancer during pregnancy: short and long term effects on mother and child.

Recruiting
Conditions
lange termijn complicaties van moeder en kind
cancer during pregnancy and outcome
10027655
10028920
Registration Number
NL-OMON54595
Lead Sponsor
Z Leuven
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1080
Inclusion Criteria

All women with a histological proven diagnosis of cancer during pregnancy or in
the first year postpartum are eligible (all types of malignancy).
Patients are at least 18 years of age.
Signed and written informed consent.
Patients do not need to participate in all parts of the study, they are allowed
to opt for some or all parts of the study.
- Registration study part: for all patients who are confronted with cancer in
pregnancy or in the first year postpartum, irrespective of outcome of pregnancy
(e.g. termination, spontaneous abortion or successful delivery) or treatment
modality during pregnancy. Patients may be included retrospectively and
prospectively in the registration part of the study
- The study of pharmacokinetics is only applicable to women undergoing
chemotherapy during pregnancy. Patients must have adequate bone marrow, renal,
hepatic and pulmonary function. WHO performance of 0 or 1.
-Patients are invited to fill in the psychological questionnaire
(quantification of psychological distress), irrespective of the cancer type or
pregnancy term. Also women who receive no active therapy are eligible for the
questionnaire.
- Long term follow up of the children who were exposed to chemotherapy and/or
radiotherapy in utero is proposed to the parents after the delivery.
-Control group of children who were born preterm on maternal indication, and
control group of a term born children of healthy mothers without cancer during
pregnancy

Exclusion Criteria

Mentally disabled or significantly altered mental status that would limit the
understanding and giving of informed consent.
Patients that are not able to read and understand the patient informed consent
form, due to language.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Maternal outcome<br /><br>Outcome of the child that is exposed to chemo and/or radiotherapy in utero.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Obstetric outcome<br /><br>Differences in diagnosis and therapy, compared to non-pregnant patients<br /><br>Differences in pharmacokinetics when chemotherapy is administered, compared to<br /><br>non-pregnant patients<br /><br>Psychological impact of the diagnosis cancer in pregnancy on the patient and<br /><br>her partner.<br /><br>Identify differences in tumor biology and genetic changes in the tumor in<br /><br>pregnancy-associated cancer, compared to non-pregnancy-associated cancer.</p><br>
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