CancerNCT00330447
Effects of Oncological Treatment During Pregnancy on Mother and Child
An observational study of Cancer and Pregnancy, run by University Hospital, Gasthuisberg at 33 sites in 20 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- How many people
- 5,000 participants
- Where
- 33 sitesin 20 countries
- Study dates
- Aug 2005to Dec 2032
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Premenopausal women with a cancer diagnosis in association with cancer
Who may be able to join
- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.
Who cannot join
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
- Part II: Follow-up of children
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Trial locations and contacts
33 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 20 countries
Italy5 sites, 5 recruiting
- Recruiting
European Institute of Oncology (2010-ongoing)
Milan
Fedro Peccatori, MD
- Recruiting
Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
Milan
Monica Fumagalli, MD
- Recruiting
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
Milan
Giovanna Scarfone, MD
- Recruiting
San Raffaele Hospital (2017-ongoing)
Milan
Giorgia Mangili, MD
- Recruiting
CIttà della Salute e della Scienza di Torino (2015-ongoing)
Torino
Bianca Masturzo, MD
Greece4 sites, 1 recruiting
- Recruiting
Euroclinic Hospital (2016-ongoing)
Athens
Georeg-Marios Makris, MD
- Terminated
Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
Athens
- Terminated
Ioannina University Hospital (retrosepctive 2015-2018)
Ioannina
- Terminated
Hippokration Hospital (retrospective 2015-2018)
Thessaloniki
Poland3 sites, 2 recruiting
- Terminated
Medyczne Macierzynstwo (retrospective 2010-2018)
Krakow
- Recruiting
University Hospital Krakow (2018-ongoing)
Krakow
Kolawa Wojciech
Marta Balajewicz-Nowak, MD
- Recruiting
Pozanan University of Medical Sciences (2017-ongoing)
Poznan
Stefan Sajdak, MD
Russia3 sites, 3 recruiting
- Recruiting
N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
Moscow
Anastasia Parokonnaya, MD
- Recruiting
Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
Moscow
Roman Shmakov, MD
- Recruiting
Almazov National Medical Research Center (2018-ongoing)
Saint Petersburg
Vladim Bezrukikh
Belgium2 sites, 2 recruiting
- Recruiting
UCL Brussels (2013-ongoing)
Brussels
Mina Mhallem, katrien.vantornout@uzleuven.be
- Recruiting
UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
Leuven, 3000
Frederic Amant, MD, PhD, +32-16-344252, frederic.amant@uzleuven.be
Kristel Van Calsteren, MD, PhD, +32-16-346192, kristel.vancalsteren@uzleuven.be
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Ostrava (2018-ongoing)
Ostrava
Jaroslav Klát, MD
- Recruiting
3rd medical faculty of Charles University (2010-ongoing)
Prague
Michael Halaska, MD
United States1 site, 1 recruiting
- Recruiting
Cooper University Hospital (2015-ongoing)
Camden, New Jersey, 08103
Elyce Cardonick, MD
Austria1 site
- Terminated
Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
Graz
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital (2015-ongoing)
Copenhagen
Lone Storgaard, MD
Berit Woetmann Pedersen, MD
France1 site
- Terminated
Hopital Bichat-Claude-Bernard (retrospective until 2018)
Paris
Germany1 site
- Terminated
Universitätsklinik Freiburg (retrospective until 2018)
Freiburg im Breisgau
Mexico1 site, 1 recruiting
- Recruiting
Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
Ixtapaluca, 56530
Álvaro Cabrera Garciá, MD
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center (2014-ongoing)
Rotterdam
Ingrid Boere, MD PHD, cip@nki.nl
Frédéric Amant, MD PHD
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital (2017-ongoing)
Bergen
Line Bjorge
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Vila Franca de Xira (2017-ongoing)
Vila Franca de Xira
Paula Duarte, MD
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital (2017-ongoing)
Stockholm
Kenny Rodriguez-Wallberg, MD
Tunisia1 site
- Terminated
F.Hached University Teaching Hospital (retrospective 2016-2018)
Sousse
Turkey (Türkiye)1 site
- Terminated
Trakya University Faculty of Medicine (retrospective 2015-2018)
Edirne
Ukraine1 site
- Terminated
Grigoriev Institute for medical Radiology (retrospective until 2018)
Kharkiv
About this study
Official title: 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).
Read the detailed description
Study contains several study parts (protocol version 4.4):
**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 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 6 months, 18 months, 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.
- Keywords
- 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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Studygroup | Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy | |
| Control group | Children from the general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up of the mothers diagnosed with cancer during pregnancy
treatment during pregnancy, obstetrical outcome, maternal survival
Measured: anticipated
Follow-up of the children antenatally exposed to chemotherapy or radiotherapy
neurologic and cardiologic outcome
Measured: anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startAug 2005
- Primary completionApr 2025 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Erasmus Medical Center, San Gerardo Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Charles University, Czech Republic
- Responsible party
- Principal investigator, Frederic Amant, University Hospital, Gasthuisberg
- Investigators
- Amant Frederic, MD PhD, Principal investigator, KULeuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330447
- Sponsor's protocol ID
- cancer in pregnancy
- Status last verified
- Mar 2024
- First submitted
- 25 May 2006
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1111/j.1525-1438.2006.00223.x.
PubMed 16681782Van 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. doi: 10.1200/JCO.2006.06.1382. No abstract available.
PubMed 16622256Lishner M, Avivi I, Apperley JF, Dierickx D, Evens AM, Fumagalli M, Nulman I, Oduncu FS, Peccatori FA, Robinson S, Van Calsteren K, Vandenbroucke T, Van den Heuvel F, Amant F. Hematologic Malignancies in Pregnancy: Management Guidelines From an International Consensus Meeting. J Clin Oncol. 2016 Feb 10;34(5):501-8. doi: 10.1200/JCO.2015.62.4445. Epub 2015 Nov 30.
PubMed 26628463Amant F, Verheecke M, Wlodarska I, Dehaspe L, Brady P, Brison N, Van Den Bogaert K, Dierickx D, Vandecaveye V, Tousseyn T, Moerman P, Vanderstichele A, Vergote I, Neven P, Berteloot P, Putseys K, Danneels L, Vandenberghe P, Legius E, Vermeesch JR. Presymptomatic Identification of Cancers in Pregnant Women During Noninvasive Prenatal Testing. JAMA Oncol. 2015 Sep;1(6):814-9. doi: 10.1001/jamaoncol.2015.1883.
PubMed 26355862de Haan J, Verheecke M, Amant F. Management of ovarian cysts and cancer in pregnancy. Facts Views Vis Obgyn. 2015;7(1):25-31.
PubMed 25897369Amant F, Han SN, Gziri MM, Vandenbroucke T, Verheecke M, Van Calsteren K. Management of cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2015 Jul;29(5):741-53. doi: 10.1016/j.bpobgyn.2015.02.006. Epub 2015 Mar 4.
PubMed 25797199van Dam L, Han SN, Dierickx D, Amant F. Optimal staging of lymphoma during pregnancy is crucial. Womens Health (Lond). 2015 Mar;11(2):101-2. doi: 10.2217/whe.14.77. No abstract available.
PubMed 25776282Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X. No abstract available.
PubMed 25705843Han SN, Verheecke M, Vandenbroucke T, Gziri MM, Van Calsteren K, Amant F. Management of gynecological cancers during pregnancy. Curr Oncol Rep. 2014 Dec;16(12):415. doi: 10.1007/s11912-014-0415-z.
PubMed 25344340Van Calsteren K, Amant F. Cancer during pregnancy. Acta Obstet Gynecol Scand. 2014 May;93(5):443-6. doi: 10.1111/aogs.12380.
PubMed 24628416Amant F, Halaska MJ, Fumagalli M, Dahl Steffensen K, Lok C, Van Calsteren K, Han SN, Mir O, Fruscio R, Uzan C, Maxwell C, Dekrem J, Strauven G, Mhallem Gziri M, Kesic V, Berveiller P, van den Heuvel F, Ottevanger PB, Vergote I, Lishner M, Morice P, Nulman I; ESGO task force 'Cancer in Pregnancy'. Gynecologic cancers in pregnancy: guidelines of a second international consensus meeting. Int J Gynecol Cancer. 2014 Mar;24(3):394-403. doi: 10.1097/IGC.0000000000000062.
PubMed 24445819Vandenbriele C, Dierickx D, Amant F, Delforge M. The treatment of hematologic malignancies in pregnancy. Facts Views Vis Obgyn. 2010;2(2):74-87. No abstract available.
PubMed 25302102Deckers S, Amant F. Breast cancer in pregnancy: a literature review. Facts Views Vis Obgyn. 2009;1(2):130-41.
PubMed 25478078Gziri MM, Goffin F, Debieve F, Amant F. [Cancer diagnosis during pregnancy: importance of a national and European registration]. Rev Med Liege. 2013 Oct;68(10):527-30. French.
PubMed 24298727Han SN, Kesic VI, Van Calsteren K, Petkovic S, Amant F; ESGO 'Cancer in Pregnancy' Task Force. Cancer in pregnancy: a survey of current clinical practice. Eur J Obstet Gynecol Reprod Biol. 2013 Mar;167(1):18-23. doi: 10.1016/j.ejogrb.2012.10.026. Epub 2012 Nov 19.
PubMed 23182070
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
- ClinicalTrials.gov ID
- NCT00330447
- Acronym / sponsor ID
- cancer in pregnancy
- Keywords
- pregnancy, in utero, chemotherapy, radiotherapy, cancer, offspring, neonatal, long term
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Erasmus Medical Center, San Gerardo Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Charles University, Czech Republic
- Study start
- Aug 2005 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 26 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study contains several study parts (protocol version 4.4):
**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 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 6 months, 18 months, 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Studygroup | – | –Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy |
| Control group | – | –Children from the general population |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Premenopausal women with a cancer diagnosis in association with cancer
Key inclusion criteria (1 listed)
- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.
Key exclusion criteria (3 listed)
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
- Part II: Follow-up of children
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 16681782Caluwaerts 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. doi: 10.1111/j.1525-1438.2006.00223.x.
- Background: PubMed 16622256Van 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. doi: 10.1200/JCO.2006.06.1382. No abstract available.
- Background: PubMed 26628463Lishner M, Avivi I, Apperley JF, Dierickx D, Evens AM, Fumagalli M, Nulman I, Oduncu FS, Peccatori FA, Robinson S, Van Calsteren K, Vandenbroucke T, Van den Heuvel F, Amant F. Hematologic Malignancies in Pregnancy: Management Guidelines From an International Consensus Meeting. J Clin Oncol. 2016 Feb 10;34(5):501-8. doi: 10.1200/JCO.2015.62.4445. Epub 2015 Nov 30.
- Background: PubMed 26355862Amant F, Verheecke M, Wlodarska I, Dehaspe L, Brady P, Brison N, Van Den Bogaert K, Dierickx D, Vandecaveye V, Tousseyn T, Moerman P, Vanderstichele A, Vergote I, Neven P, Berteloot P, Putseys K, Danneels L, Vandenberghe P, Legius E, Vermeesch JR. Presymptomatic Identification of Cancers in Pregnant Women During Noninvasive Prenatal Testing. JAMA Oncol. 2015 Sep;1(6):814-9. doi: 10.1001/jamaoncol.2015.1883.
- Background: PubMed 25897369de Haan J, Verheecke M, Amant F. Management of ovarian cysts and cancer in pregnancy. Facts Views Vis Obgyn. 2015;7(1):25-31.
- Background: PubMed 25797199Amant F, Han SN, Gziri MM, Vandenbroucke T, Verheecke M, Van Calsteren K. Management of cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2015 Jul;29(5):741-53. doi: 10.1016/j.bpobgyn.2015.02.006. Epub 2015 Mar 4.
- Background: PubMed 25776282van Dam L, Han SN, Dierickx D, Amant F. Optimal staging of lymphoma during pregnancy is crucial. Womens Health (Lond). 2015 Mar;11(2):101-2. doi: 10.2217/whe.14.77. No abstract available.
- Background: PubMed 25705843Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X. No abstract available.
- Background: PubMed 25344340Han SN, Verheecke M, Vandenbroucke T, Gziri MM, Van Calsteren K, Amant F. Management of gynecological cancers during pregnancy. Curr Oncol Rep. 2014 Dec;16(12):415. doi: 10.1007/s11912-014-0415-z.
- Background: PubMed 24628416Van Calsteren K, Amant F. Cancer during pregnancy. Acta Obstet Gynecol Scand. 2014 May;93(5):443-6. doi: 10.1111/aogs.12380.
- Background: PubMed 24445819Amant F, Halaska MJ, Fumagalli M, Dahl Steffensen K, Lok C, Van Calsteren K, Han SN, Mir O, Fruscio R, Uzan C, Maxwell C, Dekrem J, Strauven G, Mhallem Gziri M, Kesic V, Berveiller P, van den Heuvel F, Ottevanger PB, Vergote I, Lishner M, Morice P, Nulman I; ESGO task force 'Cancer in Pregnancy'. Gynecologic cancers in pregnancy: guidelines of a second international consensus meeting. Int J Gynecol Cancer. 2014 Mar;24(3):394-403. doi: 10.1097/IGC.0000000000000062.
- Background: PubMed 25302102Vandenbriele C, Dierickx D, Amant F, Delforge M. The treatment of hematologic malignancies in pregnancy. Facts Views Vis Obgyn. 2010;2(2):74-87. No abstract available.
- This site provides background information on the problem of cancer in pregnancy and details further the project.Link provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amant Frederic, MD PhD principal investigator
KULeuven, Belgium
33 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pregnancy, run by University Hospital, Gasthuisberg at 33 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy, Greece, Poland, Russia, Belgium and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayaka Wakatsuki (+32 16 34 41 69, ayaka.wakatsuki@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up of the mothers diagnosed with cancer during pregnancy (time frame: anticipated). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330447, which also lists 73 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.