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Effects of Oncological Treatment During Pregnancy on Mother and Child

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ClinicalTrials.gov Identifier: NCT00330447
Recruitment Status : Recruiting
First Posted : May 26, 2006
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Laurence Claes, PhD
Ingrid Boere, MD PhD
Michael Halaska, MD PhD
Lagae, Lieven, M.D., Ph.D.
Mertens, Luc, M.D., Ph.D.
Monica Fumagalli, MD PhD
Kristel Van Calsteren, MD PhD
Christianne Lok, MD PhD
Robert Fruscio, MD PhD
Marry van den Heuvel-Eibrink, MD PhD
Information provided by (Responsible Party):
Frederic Amant, University Hospital, Gasthuisberg

May 25, 2006
May 26, 2006
May 22, 2018
August 2005
April 2025   (Final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00330447 on ClinicalTrials.gov Archive Site
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Effects of Oncological Treatment During Pregnancy on Mother and Child
Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
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).

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
18 Years
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample
Premenopausal women with a cancer diagnosis in association with cancer
  • Cancer
  • Pregnancy
Not Provided
  • Studygroup
    Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
  • Control group
    Children from the general population

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
50
December 2032
April 2025   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact: Katrien Van Tornout +32-16-342876 katrien.vantornout@uzleuven.be
Contact: Kristel Van Calsteren, MD PhD +32-16-346192 kristel.vancalsteren@uzleuven.be
Belgium,   Mexico,   Netherlands,   Russian Federation
 
 
NCT00330447
cancer in pregnancy
No
Not Provided
Not Provided
Frederic Amant, University Hospital, Gasthuisberg
University Hospital, Gasthuisberg
  • Laurence Claes, PhD
  • Ingrid Boere, MD PhD
  • Michael Halaska, MD PhD
  • Lagae, Lieven, M.D., Ph.D.
  • Mertens, Luc, M.D., Ph.D.
  • Monica Fumagalli, MD PhD
  • Kristel Van Calsteren, MD PhD
  • Christianne Lok, MD PhD
  • Robert Fruscio, MD PhD
  • Marry van den Heuvel-Eibrink, MD PhD
Principal Investigator: Amant Frederic, MD PhD KULeuven, Belgium
University Hospital, Gasthuisberg
May 2018