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Cancer in pregnancy International multicentric study concerning women who are diagnosed with cancer in pregnancy. Go to the Cancer in Pregnancy website Background It is estimated that 1 in 1000-1500 pregnant women are confronted with cancer every year. The most frequent cancers in fertile women are breast and cervical cancer, leukemia, lymphoma and melanoma. Treatment is an enormous challenge during pregnancy, the application of chemotherapy, radiotherapy or surgery under such circumstances raises many questions. Doctors have to consider both the recovery of the mother as well as the wellbeing of the unborn child. If pregnant women recieve the same treatment as non-pregnant women, their prognosis is probably the same. Concern for fetal anomalies due to oncological treatment can warrant termination of pregnancy. Decision-making is most difficult in the second trimester. Postponement of treatment until fetal viability might reduce the mother’s chances for survival. On the other hand, premature birth can have detrimental consequences for the child. Nonetheless, oncological treatment can be initiated during pregnancy to offer both mother and child the greatest chances. There are provisionally no indications that chemotherapy during pregnancy has a direct damaging effect on the fetus. Radiotherapy on the upper-body is also possible. The absence of serious birth defects indicates that both treatment modalities are relatively safe. However, limited research has been carried out on long term development of the child that has been exposed to cytotoxic treatment in utero. The few studies that report on this are indeed reassuring, but furthur research remains necessary. Research project A research project was established in 2004 in order to acquire better insights into this complex issue. Participating countries so far: - The first part of this project is a registration study, both retrospective and prospectively examining the oncological treatments that are given to pregnant women. Furthermore, maternal outcome and the influence of oncologic therapies on foetal development and the health of the child at birth are registered. - The second part investigates psychological impact for both parents. Most women are highly distressed at having to cope with cancer during pregnancy, this has not been quantified until now. Further research is necessary in order to assess the type of psychologic support that is needed in order to prevent long term emotional damage. Parents are invited to fill out a questionnaire twice, during cancer treatment and also 18 months after birth. - The third part is of a pharmacological nature; it analyses the “pharmacokinetics” of chemotherapy in pregnant women (i.e. the absorption, progression and distribution of the medication in the body) and the “transplacental transfer” of the medication (transfer through the placenta) to the foetus. During 1-2 cycles of chemotherapy, a number of blood samples will be taken in order to compare plasma drug levels with the non-pregnant patient recieving the same chemotherapy. - The fourth part focuses on the effects of prenatal exposure to chemotherapy or radiotherapy on the general, cardiac and neurological development of the child. This consists of long term follow up at age 18 months, 6, 9, 12, 15 and 18 years. The tests are performed by specialized pediatricians and neurologists in UMC Radboud Nijmegen, UZ Leuven, Belgium or Inclusion criteria - All pregnant women that are confronted with cancer during pregnancy are invited to participate with the first and second part (registration study and quantification of psychological distress), irrespective of cancer type or pregnancy term. Also women who recieve no active therapy are eligible. - The third part (pharmacokinetics) is only applicable to women undergoing chemotherapy. - The fourth part consists of long term follow up of the child, this is proposed to the parents after the delivery. Principal Investigator Investigators for the Nelleke Ottevanger, M.D., Ph.D. Sileny Han, M.D., Obstetrics & Gynaecology, UZ Gasthuisberg, KULeuven Herestraat 49, 3000 Leuven, Belgium Contact F. Amant: frederic.amant@uz.kuleuven.ac.be Tel. België: +32 16 344252 (secretary) S. N. Han: silenynaeyu.han@uz.kuleuven.ac.be Tel. Nederland: +31 628469233 Tel. België: +32 16 344252 (secretary)
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