AzTrials
AzTrials

Pregnancy, Cancer, Cancer in Pregnancy, Gestational Breast Cancer, Pregnancy RelatedCANCRPREGREGNCT02749474

Maternal Cancer Diagnosis and Treatment During Pregnancy:a Database for Maternal, Fetal, and Neonatal Outcomes

An observational study of Pregnancy, Cancer, Cancer in Pregnancy, Gestational Breast Cancer, Pregnancy Related, run by Cooper Norcross Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of this study is to follow the treatment options offered to pregnant women diagnosed with cancer and study the impact that their treatment or delay of treatment has on their own health and that of their children. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
How many people
400 participants
Where
1 siteUnited States
Study dates
1 Jul 2003to 30 Dec 2028
How long will I take part?
20 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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Cohort of pregnant women diagnosed with any type of cancer.

Who may be able to join

  • Any pregnant woman diagnosed with cancer within 6 weeks before her last menstrual period or 6 months after her end of pregnancy either by delivery or miscarriage.

Who cannot join

  • Women diagnosed with cancer more than 6 months after the end of a pregnancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Harry Mazurek contact

8563422000

United States1 site, 1 recruiting
  • Cooper University Hospital

    Camden, New Jersey, 08103

    Elyce H Cardonick, MD, 8563422065 or 8567577876, cancerandpregnancy@cooperhealth.edu

    Alexander Santangelo, BA, 8563422473, santangelo-alexander@CooperHealth.edu

    Recruiting

Other trials in United States

About this study

Official title: Maternal Cancer Diagnosis and Treatment During Pregnancy:a Registry for Maternal, Fetal, and Neonatal Outcomes With Longitudinal Follow up of Child Development and Maternal Psychological Well Being

The objective of this study is to follow the treatment options offered to pregnant women diagnosed with cancer and study the impact that their treatment or delay of treatment has on their own health and that of their children.

Read the detailed description

Approximately 1:1000 pregnancies are complicated by cancer. Breast cancer is the most common type diagnosed during pregnancy. Termination of pregnancy has not demonstrated an improvement in survival. Results of an international collaborative study reported similar overall survival for patients diagnosed with breast cancer in pregnancy compared to non-pregnant patients. The consensus medical opinion supports the option to start treatment with continuation of the pregnancy. The purpose of this Cancer and Pregnancy Registry study is to prospectively follow the women diagnosed with cancer during pregnancy-collecting information about the method of diagnosis, treatment options and maternal and neonatal outcomes at delivery and yearly at follow up during childhood and adult development. Some children in this cohort have been followed up to 28 years of age.

The majority of fetal organ development is completed by 12 weeks of pregnancy, consistent with the literature showing no increased malformation rate for chemotherapy use after the first trimester of pregnancy. The central nervous system continues to develop throughout gestation and after birth. Whether chemotherapy given after the first trimester affects central nervous system maturity and results in developmental delays requires further study. The first authors to provide detailed follow up on children exposed to chemotherapy in utero were Aviles and Niz in 1988. At that time 17 children ranging in age from 4-22 years born to mothers with acute leukemia who received chemotherapy during pregnancy were examined for physical health, growth and development. Each child demonstrated normal growth and development, school performance, intelligence testing, neurological examination, and hematologic evaluation including bone marrow biopsies. This study was expanded twice. First in 1991, to 43 children ranging in age from 3 to 19 years, also after exposure in utero to chemotherapy for maternal hematologic malignancies. All children were normal physically and neurologically. School performances and standardized intelligence testing were not significantly different from controls (unrelated matched children and unexposed siblings). The same authors expanded their study again to a final report of 84 children in 2001, confirming their previous reports that chemotherapy at full doses for an aggressive hematological malignancy can be safely administered. Standardized testing on children exposed to chemotherapy was not repeated for 11 years. Drs. Amant, et al reported developmental outcomes of 70 children in Europe exposed to cancer treatment in utero. The children with developmental delays were concentrated in the group delivered preterm. In this study there was not a control group of unexposed children.

Cardonick also performed developmental testing on 57 children of women diagnosed with cancer during pregnancy, 35 were exposed to chemotherapy. Ninety-five percent of children scored within normal limits on cognitive assessments; 71% and 79% of children demonstrated at or above age equivalency in mathematics and reading scores respectively. Together Dr Cardonick and Dr Amant have evaluated children up to age 9 who were exposed to chemotherapy before birth. Reassuringly chemotherapy did not impact neurologic development, or heart performance up to age 9 years. A current study is looking at children at age 12. Studies are looking at children after exposure to both chemotherapy or radiation or cancer surgery during pregnancy. Currently Dr Cardonick is in contact with young adults in the study who are at least 18 years of age who are participating in a self-assessment tool of their physical, mental and social health. Such long follow up is what helps newly diagnosed pregnant women make informed decisions about cancer treatment during pregnancy.

Women diagnosed with cancer of any type during pregnancy can enroll voluntarily in the Cancer and Pregnancy Registry. Signed medical release forms allow the investigator to review cancer diagnostic studies and treatment course. Records are requested yearly from the treating pediatrician to follow the growth and development of the child. Participants do not have to collect their own records. All information is kept confidential. Oncologic follow up on the women is also requested yearly.

Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02749474
Study groupRoleWhat they receive
Pregnant women diagnosed with cancerAny pregnant woman diagnosed with any cancer within 6 weeks prior to their last menstrual period, or up to 6 months after the end of their pregnancy can be enrolled.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal Developmental Quotient

    Pediatrician asked to assess developmental age compared to chronological age, ie developmental quotient

    Measured: Yearly from 3 months to 12 years of age

Secondary outcomes (1)
  1. Congenital Malformations

    Incidence of children in registry diagnosed with birth defects after a pregnancy complicated by a cancer diagnosis.

    Measured: From birth to 5 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2016 (estimated)
  2. Study start1 Jul 2003
  3. Primary completion30 Jul 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

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
400 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749474
Sponsor's protocol ID
Cooper 15-028
Acronym
CANCRPREGREG
Status last verified
Mar 2026
First submitted
13 Apr 2016
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Cardonick E. Pregnancy-associated breast cancer: optimal treatment options. Int J Womens Health. 2014 Nov 4;6:935-43. doi: 10.2147/IJWH.S52381. eCollection 2014.

    PubMed 25395871
  • Cardonick E. Treatment of maternal cancer and fetal development. Lancet Oncol. 2012 Mar;13(3):218-20. doi: 10.1016/S1470-2045(11)70408-9. Epub 2012 Feb 10. No abstract available.

    PubMed 22326923
  • Cardonick E. Cancer occurs in approximately 1 per 1,000 pregnancies. Oncology (Williston Park). 2008 Jul;22(8 Suppl Nurse Ed):22-3. No abstract available.

    PubMed 19856567
  • Cardonick E, Iacobucci A. Use of chemotherapy during human pregnancy. Lancet Oncol. 2004 May;5(5):283-91. doi: 10.1016/S1470-2045(04)01466-4.

    PubMed 15120665
  • Levy C, Pereira L, Dardarian T, Cardonick E. Solid pseudopapillary pancreatic tumor in pregnancy. A case report. J Reprod Med. 2004 Jan;49(1):61-4.

    PubMed 14976799
  • Berghella V, Broth RE, Chapman AE, Cardonick E. Metastatic unknown primary tumor presenting in pregnancy as multiple cerebral infarcts. Obstet Gynecol. 2003 May;101(5 Pt 2):1060-2. doi: 10.1016/s0029-7844(02)02333-5.

    PubMed 12738101
  • Partridge AH, Pagani O, Abulkhair O, Aebi S, Amant F, Azim HA Jr, Costa A, Delaloge S, Freilich G, Gentilini OD, Harbeck N, Kelly CM, Loibl S, Meirow D, Peccatori F, Kaufmann B, Cardoso F. First international consensus guidelines for breast cancer in young women (BCY1). Breast. 2014 Jun;23(3):209-20. doi: 10.1016/j.breast.2014.03.011. Epub 2014 Apr 24.

    PubMed 24767882
  • Vandenbroucke T, Amant F. Development of children born to mothers with cancer during pregnancy: comparing in utero chemotherapy-exposed children with nonexposed controls. Am J Obstet Gynecol. 2015 Jun;212(6):830-1. doi: 10.1016/j.ajog.2015.01.035. Epub 2015 Jan 28. No abstract available.

    PubMed 25637847
  • 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.

    PubMed 26415085
  • Aviles A, Diaz-Maqueo JC, Talavera A, Guzman R, Garcia EL. Growth and development of children of mothers treated with chemotherapy during pregnancy: current status of 43 children. Am J Hematol. 1991 Apr;36(4):243-8. doi: 10.1002/ajh.2830360404.

    PubMed 1707227
  • Aviles A, Neri N. Hematological malignancies and pregnancy: a final report of 84 children who received chemotherapy in utero. Clin Lymphoma. 2001 Dec;2(3):173-7. doi: 10.3816/clm.2001.n.023.

    PubMed 11779294
  • Aviles A, Niz J. Long-term follow-up of children born to mothers with acute leukemia during pregnancy. Med Pediatr Oncol. 1988;16(1):3-6. doi: 10.1002/mpo.2950160102.

    PubMed 3340063
  • Stopenski S, Aslam A, Zhang X, Cardonick E. After Chemotherapy Treatment for Maternal Cancer During Pregnancy, Is Breastfeeding Possible? Breastfeed Med. 2017 Mar;12:91-97. doi: 10.1089/bfm.2016.0166. Epub 2017 Feb 7.

    PubMed 28170295
  • Han SN, Amant F, Cardonick EH, Loibl S, Peccatori FA, Gheysens O, Sangalli CA, Nekljudova V, Steffensen KD, Mhallem Gziri M, Schroder CP, Lok CAR, Verest A, Neven P, Smeets A, Pruneri G, Cremonesi M, Gentilini O; International Network on Cancer, Infertility and Pregnancy. Axillary staging for breast cancer during pregnancy: feasibility and safety of sentinel lymph node biopsy. Breast Cancer Res Treat. 2018 Apr;168(2):551-557. doi: 10.1007/s10549-017-4611-z. Epub 2017 Dec 12.

    PubMed 29235045
  • de Haan J, Verheecke M, Van Calsteren K, Van Calster B, Shmakov RG, Mhallem Gziri M, Halaska MJ, Fruscio R, Lok CAR, Boere IA, Zola P, Ottevanger PB, de Groot CJM, Peccatori FA, Dahl Steffensen K, Cardonick EH, Polushkina E, Rob L, Ceppi L, Sukhikh GT, Han SN, Amant F; International Network on Cancer and Infertility Pregnancy (INCIP). Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients. Lancet Oncol. 2018 Mar;19(3):337-346. doi: 10.1016/S1470-2045(18)30059-7. Epub 2018 Jan 26.

    PubMed 29395867

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, Cancer, Cancer in Pregnancy, Gestational Breast Cancer, Pregnancy Related, run by Cooper Norcross Health at 1 site in United States.

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 1 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 Elyce H Cardonick, MD (856342 2065, cancerandpregnancy@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal Developmental Quotient (time frame: Yearly from 3 months to 12 years of age). 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 NCT02749474, which also lists 29 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 22 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in