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Status:

RECRUITING

Effects of Oncological Treatment During Pregnancy on Mother and Child

Lead Sponsor:

University Hospital, Gasthuisberg

Collaborating Sponsors:

The Netherlands Cancer Institute

Erasmus Medical Center

Conditions:

Cancer

Pregnancy

Eligibility:

FEMALE

18+ years

Brief 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 wh...

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 pregna...

Eligibility Criteria

Inclusion

  • Patients do not need to participate in both; however, preferentially both study parts should be performed.
  • \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part I: Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\*\*\*\*\*
  • Patients must meet the following inclusion criteria:
  • Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy)
  • \> 18 years of age, premenopausal
  • 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 or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II).

Exclusion

  • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
  • \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\*
  • Inclusion Criteria:
  • \- 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 Trial Info

Start Date :

August 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2032

Estimated Enrollment :

5000 Patients enrolled

Trial Details

Trial ID

NCT00330447

Start Date

August 1 2005

End Date

December 1 2032

Last Update

March 6 2024

Active Locations (33)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (33 locations)

1

Cooper University Hospital (2015-ongoing)

Camden, New Jersey, United States, 08103

2

Instituto Alexander Fleming

Buenos Aires, Argentina

3

Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)

Graz, Austria

4

UCL Brussels (2013-ongoing)

Brussels, Belgium