Effects of Oncological Treatment During Pregnancy on Mother and Child
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00330447 |
Recruitment Status :
Recruiting
First Posted : May 26, 2006
Last Update Posted : November 18, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Cancer Pregnancy |
Study contains several study parts (protocol version 4.2):
**********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 I.III. Biobank 'cancer and pregnancy' From participating women, a tumour biopsy specimen before administration of neoadjuvant therapy will be collected at the time of diagnosis. Also, maternal blood samples will be collected before and/or after treatment.
Part I.IV. Study on the pharmacokinetics of chemotherapeutic agents in pregnant women Approximately 10-12 additional peripheral venous blood withdrawals.
**********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 18months, 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 Type : | Observational [Patient Registry] |
Estimated Enrollment : | 5000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 18 Years |
Official Title: | Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring |
Study Start Date : | August 2005 |
Estimated Primary Completion Date : | April 2025 |
Estimated Study Completion Date : | December 2032 |
Group/Cohort |
---|
Studygroup
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
|
Control group
Children from the general population
|
- Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ]treatment during pregnancy, obstetrical outcome, maternal survival
- Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ]neurologic and cardiologic outcome
Biospecimen Retention: Samples With DNA
Maternal blood serum and sediment of blood; from 2010 on we collect umbilical cord blood.
Since new approval of protocol version 4.2 (08-02-2018) we collect samples of placental tissue, umbilical cord tissue and membranes.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Exclusion Criteria:
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330447
Contact: Katrien Van Tornout | +32-16-342876 | katrien.vantornout@uzleuven.be | |
Contact: Kristel Van Calsteren, MD PhD | +32-16-346192 | kristel.vancalsteren@uzleuven.be |

Principal Investigator: | Amant Frederic, MD PhD | KULeuven, Belgium |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Frederic Amant, MD, PhD, University Hospital, Gasthuisberg |
ClinicalTrials.gov Identifier: | NCT00330447 |
Other Study ID Numbers: |
cancer in pregnancy |
First Posted: | May 26, 2006 Key Record Dates |
Last Update Posted: | November 18, 2020 |
Last Verified: | November 2020 |
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 |