RECRUITING

Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)

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

PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally. Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment. By collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta. This study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient. The investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.

Official Title

Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions

Quick Facts

Study Start:2017-03-21
Study Completion:2035-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06940323

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:18 Years to 64 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant or contemplating pregnancy
  2. * Female, aged 18 to 64 years
  3. * Diagnosis of one of the following conditions:
  4. * Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria
  5. * Neuromyelitis Optica Spectrum Disorder (NMOSD)
  6. * Inflammatory Bowel Disease (IBD)
  7. * Rheumatoid Arthritis (RA)
  8. * Myasthenia Gravis
  9. * Lupus
  10. * Other chronic neurological conditions
  11. * Willing to provide biosamples and/or complete surveys at specified timepoints
  12. * Women without a chronic condition who are pregnant or contemplating pregnancy (as part of the control group)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Min Ji Kim Kim, BA
CONTACT
415-502-7209
minji.kim3@ucsf.edu

Principal Investigator

Riley Bove, MD, MSc
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California-San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Riley Bove, MD, MSc, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Date2017-03-21
Study Completion Date2035-06

Study Record Updates

Study Start Date2017-03-21
Study Completion Date2035-06

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis
  • Clinically Isolated Syndrome
  • NMOSD
  • Myasthenia Gravis