Effects of Oncological Treatment During Pregnancy - Full Text View

Purpose

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 cytotoxic drugs in utero, or radiotherapy, develop normally (neurologic and cardiologic examination).

Condition
Cancer Pregnancy


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration:	5 Years
Official Title:	Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:

Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ] [ Designated as safety issue: Yes ]
Overall survival
Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ] [ Designated as safety issue: Yes ]
neurologic and cardiologic outcome

Biospecimen Retention: None Retained

serum and sediment of blood; from 2010 on we collect umbilical cord blood


Estimated Enrollment:	5000
Study Start Date:	August 2005
Estimated Study Completion Date:	April 2020
Estimated Primary Completion Date:	April 2020 (Final data collection date for primary outcome measure)

Groups/Cohorts
Studygroup Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
Control group Children from the general population

Detailed Description:

Prospectively the outcome of mothers diagnosed and/or treated for cancer during pregnancy will be registered and investigated.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

pregnant women diagnosed with cancer

Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria:

Histologically proven cancer
Patients must have adequate bone marrow, renal, hepatic and pulmonary function.
World Health Organization (WHO) performance status of 0 or 1
> 18 years of age
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 during pregnancy are allowed for the assessment of the maternal and fetal outcome
Patients are allowed to opt for the pharmacokinetic part or clinical follow-up part of the study only and do not need to participate in both; however, preferentially both study parts should be performed.
Women receiving any kind of radiotherapy during pregnancy

Exclusion Criteria:

Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330447

Contacts


Contact: Liesbeth Leemans	+32-16-344634/5	Liesbeth.leemans@uzleuven.be
Contact: Kristel Van Calsteren, MD PhD	+32-16-346192	kristel.vancalsteren@uzleuven.be

Locations


Belgium
UZ Gasthuisberg, Katholieke Universiteit Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant, MD, PhD +32-16-344252 frederic.amant@uzleuven.be
Contact: Kristel Van Calsteren, MD, PhD +32-16-346192 kristel.vancalsteren@uzleuven.be
Sub-Investigator: Lieven Lagae, MD, PhD
Sub-Investigator: Luc Mertens, MD, PhD
Principal Investigator: Frederic Amant, MD, PhD
Sub-Investigator: Kristel Van Calsteren, MD
Sub-Investigator: Ingrid Boere, MD PhD
Sub-Investigator: Michael Halaska, MD
Sub-Investigator: Laurence Claes, PhD
Sub-Investigator: Monica Fumagalli, MD PhD

Sponsors and Collaborators

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

Investigators


Principal Investigator:	Amant Frederic, MD PhD	KULeuven, Belgium

More Information

Additional Information:

This site provides background information on the problem of cancer in pregnancy and details further the project. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Van Calsteren K, Heyns L, De Smet F, Van Eycken L, Gziri MM, Van Gemert W, Halaska M, Vergote I, Ottevanger N, Amant F. Cancer during pregnancy: an analysis of 215 patients emphasizing the obstetrical and the neonatal outcomes. J Clin Oncol. 2010 Feb 1;28(4):683-9. doi: 10.1200/JCO.2009.23.2801. Epub 2009 Oct 19.

Amant F, Van Calsteren K, Halaska MJ, Gziri MM, Hui W, Lagae L, Willemsen MA, Kapusta L, Van Calster B, Wouters H, Heyns L, Han SN, Tomek V, Mertens L, Ottevanger PB. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study. Lancet Oncol. 2012 Mar;13(3):256-64. doi: 10.1016/S1470-2045(11)70363-1. Epub 2012 Feb 10.

Gziri MM, Debiève F, DE Catte L, Mertens L, Barrea C, VAN Calsteren K, Han SN, Heyns L, Amant F. Chemotherapy during pregnancy: effect of anthracyclines on fetal and maternal cardiac function. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1465-8. doi: 10.1111/j.1600-0412.2012.01524.x. Epub 2012 Nov 1.

Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Müller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. Treatment of breast cancer during pregnancy: an observational study. Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16.

Gziri MM, Amant F, Debiève F, Van Calsteren K, De Catte L, Mertens L. Effects of chemotherapy during pregnancy on the maternal and fetal heart. Prenat Diagn. 2012 Jul;32(7):614-9. doi: 10.1002/pd.3847. Epub 2012 Apr 17. Review.

Mhallem Gziri M, Han SN, Van Calsteren K, Heyns L, Delaere P, Nuyts S, Van den Heuvel F, Cheron AC, Fossion E, Van den Weyngaert D, Lok C, Amant F. Tongue cancers during pregnancy: Case reports and review of literature. Head Neck. 2013 Apr;35(4):E102-8. doi: 10.1002/hed.21924. Epub 2011 Oct 19. Review.

Gziri MM, Hui W, Amant F, Van Calsteren K, Ottevanger N, Kapusta L, Mertens L. Myocardial function in children after fetal chemotherapy exposure. A tissue Doppler and myocardial deformation imaging study. Eur J Pediatr. 2013 Feb;172(2):163-70. doi: 10.1007/s00431-012-1849-7. Epub 2012 Oct 5.

Boussios S, Han SN, Fruscio R, Halaska MJ, Ottevanger PB, Peccatori FA, Koubková L, Pavlidis N, Amant F. Lung cancer in pregnancy: report of nine cases from an international collaborative study. Lung Cancer. 2013 Dec;82(3):499-505. doi: 10.1016/j.lungcan.2013.09.002. Epub 2013 Sep 12.

Amant F, von Minckwitz G, Han SN, Bontenbal M, Ring AE, Giermek J, Wildiers H, Fehm T, Linn SC, Schlehe B, Neven P, Westenend PJ, Müller V, Van Calsteren K, Rack B, Nekljudova V, Harbeck N, Untch M, Witteveen PO, Schwedler K, Thomssen C, Van Calster B, Loibl S. Prognosis of women with primary breast cancer diagnosed during pregnancy: results from an international collaborative study. J Clin Oncol. 2013 Jul 10;31(20):2532-9. doi: 10.1200/JCO.2012.45.6335. Epub 2013 Apr 22.

Verheecke M, Halaska MJ, Lok CA, Ottevanger PB, Fruscio R, Dahl-Steffensen K, Kolawa W, Gziri MM, Han SN, Van Calsteren K, Van den Heuvel F, De Vleeschouwer S, Clement PM, Menten J, Amant F; ESGO Task Force ‘Cancer in Pregnancy’. Primary brain tumours, meningiomas and brain metastases in pregnancy: report on 27 cases and review of literature. Eur J Cancer. 2014 May;50(8):1462-71. doi: 10.1016/j.ejca.2014.02.018. Epub 2014 Mar 14. Review.

Caluwaerts S, VAN Calsteren K, Mertens L, Lagae L, Moerman P, Hanssens M, Wuyts K, Vergote I, Amant F. Neoadjuvant chemotherapy followed by radical hysterectomy for invasive cervical cancer diagnosed during pregnancy: report of a case and review of the literature. Int J Gynecol Cancer. 2006 Mar-Apr;16(2):905-8.

Van Calsteren K, Berteloot P, Hanssens M, Vergote I, Amant F, Ganame J, Claus P, Mertens L, Lagae L, Delforge M, Paridaens R, Noens L, Humblet Y, Vandermeersch B, De Muylder X. In utero exposure to chemotherapy: effect on cardiac and neurologic outcome. J Clin Oncol. 2006 Apr 20;24(12):e16-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Amant F, Vandenbroucke T, Verheecke M, Fumagalli M, Halaska MJ, Boere I, Han S, Gziri MM, Peccatori F, Rob L, Lok C, Witteveen P, Voigt JU, Naulaers G, Vallaeys L, Van den Heuvel F, Lagae L, Mertens L, Claes L, Van Calsteren K; International Network on Cancer, Infertility, and Pregnancy (INCIP). Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2015 Nov 5;373(19):1824-34. doi: 10.1056/NEJMoa1508913. Epub 2015 Sep 28.


Responsible Party:	Frederic Amant, MD PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:	NCT00330447 History of Changes
Other Study ID Numbers:	cancer in pregnancy
Study First Received:	May 25, 2006
Last Updated:	December 2, 2015
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital, Gasthuisberg:


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

ClinicalTrials.gov processed this record on September 23, 2016