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Effects of Oncological Treatment During Pregnancy on Mother and Child

University Hospital, Gasthuisberg · with The Netherlands Cancer Institute, Erasmus Medical Center · NCT00330447

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
5000
US sites recruiting
1
Study start
August 2005
Record last updated
March 6, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Conditions: Cancer; Pregnancy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 Criteria

  • 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.

Exclusion Criteria

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

Recruiting US locations

  • Cooper University Hospital (2015-ongoing)

    Camden, NJ 08103

    Site contact: Elyce Cardonick, MD

Study contacts (from the official record)

  • Ayaka Wakatsuki · +32 16 34 41 69 · ayaka.wakatsuki@uzleuven.be
  • Kristel Van Calsteren, MD PhD · +32-16-346192 · kristel.vancalsteren@uzleuven.be
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Effects of Oncological Treatment During Pregnancy on Mother and Child (NCT00330447) | Bored Studies