RECRUITING

The Mycophenolate Pregnancy Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified. This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.

Official Title

The Mycophenolate Pregnancy Registry

Quick Facts

Study Start:2012-11-30
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01733082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
  1. * Pregnancies for which there is paternal exposure only
  2. * Pregnancies occurring outside the U.S.

Contacts and Locations

Study Contact

Reference Study ID Number: ML22679 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
global.rochegenentechtrials@roche.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Genentech, Inc.

Study Locations (Sites)

Quintiles Outcome
Cambridge, Massachusetts, 02139
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-11-30
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2012-11-30
Study Completion Date2025-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases