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Cancer in Pregnancy Study (CIP)


An international multicenter study concerning women who are diagnosed with cancer in pregnancy.
 
Go to the Cancer in Pregnancy website


Background
The incidence of cancer during pregnancy is approximately one in 1000-1500 pregnancies. In The Netherlands up to 200 women are confronted with this diagnosis every year. It is expected that this number will increase due to the increasing maternal age and the improved diagnostic possibilities during pregnancy. The most common types of cancer are breast cancer, cervix cancer, hematological malignancies, melanoma and ovarian cancer. Performing diagnostic- and therapeutic interventions in pregnant women with cancer causes medical, ethical and psychological dilemmas for both caretakers and parents. A routine therapeutic termination of pregnancy is not advised since pregnancy itself does not seem to influence prognosis. Recent studies show that several 'standard' interventions for the non-pregnant population are relatively safe for the unborn child when using additional protection. A multidisciplinary approach with a team of obstetricians, surgeons, medical oncologists, radiotherapists, pediatricians, phycologists and pharmacologists is therefore necessary in providing the best possible care for the pregnant woman with cancer. Since the incidence of cancer in pregnancy is low and the population diverse, it is important to centralize the knowledge on cancer in pregnancy and to further investigate the treatment possibilities for this patient population in order to improve care for both mother and child. 


Research project
A research project was established in 2005 by the 'Cancer in Pregnancy' taskforce in order to improve insights in the diagnosis and treatment of cancer in pregnancy. In 2014 this taskforce was transformed into the 'International Network on Cancer, Infertility and Pregnancy'. Up till now over 60 medical centres from 25 different countries are participating. The 'Cancer in Pregnancy' study (CIP study) is divided in 5 parts:


Part I:
Part I is a registration study including all patients diagnosed with cancer during pregnancy or with a pregnancy during active treatment. Data will be collected both retrospectively and prospectively on tumour characteristics, diagnostic- and therapeutic interventions and on the oncological, fetal, neonatal and maternal outcome.
Inclusion criteria: All women with histologically confirmed cancer during pregnancy or pregnancy during active treatment of cancer.


Part II:
Part II is a study on the pharmacokinetics of chemotherapy in pregnant women compared to non-pregnant women. During a cycle of chemotherapy five blood samples will be collected in order to analyse the concentration of chemotherapy and compare ‘area under the curve’, peak plasma concentration, distribution of drugs and clearance with non-pregnant controls. A secondary endpoint is the difference in toxicity of chemotherapy between pregnant and non-pregnant women. 
Inclusion criteria: All women who are treated with chemotherapy during pregnancy.


Part III:
Part III focuses on the effects of prenatal exposure to chemotherapy or radiotherapy on the general, cardiac and neurological development of the child. Children will be seen at the age of 18 months, 3, 6, 9, 12, 15 and 18 years. The tests are performed by paediatricians, cardiac ultrasound specialists and psychologist in the VU Medical Centre or University Hospitals Leuven, Belgium. Study children will be compared with healthy children from healthy mothers and with premature children born without exposure to chemotherapy or radiotherapy.
Inclusion criteria: Children exposed to chemotherapy and/or radiotherapy in utero.


Part IV:
Part IV studies the histological, biological and genetic differences in pregnancy-associated breast cancer. It is known that different markers in breast cancer are known to predict outcome and are an opportunity for targeted therapy. Changes during pregnancy are not well known.
Inclusion criteria: Women who are eligible for this study are patients with breast cancer diagnosed during pregnancy or within one year after delivery. Tissue must be collected before chemo-, radiation- or targeted therapy.


Part V:
Part V focuses on the psychological impact of cancer in pregnancy for both parents. It is assumed that women will be distressed when having to cope with cancer during pregnancy. Different coping strategies may affect decision-making. Identifying inadequate coping strategies facilitates guidance of these patients and their partners in an attempt to reduce stress levels, aid decision-making and to prevent long-term emotional damage. In this study patients and partners will be invited to fill out a questionnaire, with questions on their thoughts about the effect of cancer on the mothers health, their baby, the delivery and their relationship.
Inclusion criteria: All women and partners of women who have cancer during pregnancy or pregnancy during active cancer treatment. 
 

Principal Investigator
Frederic Amant, M.D., PhD.
Gynaecologic Oncology
University Hospitals Leuven
Herestraat 49
3000 Leuven, Belgium
frederic.amant@uzleuven.be
 

Investigators for the Netherlands
Ingrid Boere, M.D., PhD.
Medical Oncology
Erasmus MC Cancer Institute
’s Gravendijkwal 230
3015 CE Rotterdam, The Netherlands
i.boere@erasmusmc.nl
Tel: +31 10 7034897
Fax: +31 10 7034627

Christianne Lok, M.D., PhD.
Gynaecologic Oncology
Center for Gynaecologic Oncology Amsterdam (CGOA)
Plesmanlaan 121
1066 CX Amsterdam, The Netherlands
c.lok@nki.nl
Tel: +31 20 5122975