The Women's Health Study: From Adolescence to Adulthood

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Children's Hospital Boston
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Marc R Laufer, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01738204
First received: November 28, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

In order to learn more about women's health issues that occur over the lifespan, the Women's Health Study: from Adolescence to Adulthood is building a biorepository and database. The biorepository collects, processes and stores samples (such as urine, saliva, blood, cells, tissue and peritoneal fluid) until they are needed for research. The database contains de-identified information about our study participants. The biorepository and database are being created to serve as a resource for researchers from Boston Children's Hospital, Brigham and Women's Hospital and outside institutions.


Condition
Pelvic Pain
Endometriosis
Dysmenorrhea
Gynecology
Reproductive Medicine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Women's Health Study: From Adolescence to Adulthood Sponsored by the Boston Center for Endometriosis.

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Establishing a biorepository and database [ Time Frame: next 20 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

urine, saliva, blood, tissue, peritoneal fluid


Estimated Enrollment: 2000
Study Start Date: November 2012
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females with endometriosis
Females with a surgical diagnosis of endometriosis or who undergoing surgery for suspected endometriosis. At this time, we are only recruiting patients of Boston Children's Hospital and Brigham and Women's Hospital for this group.
Females without surgical diagnosis of endometriosis
Females do not need to be patients of Boston Children's Hospital or Brigham and Women's Hospital.

  Eligibility

Ages Eligible for Study:   7 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

clinic and community sample

Criteria

Inclusion Criteria:

  • female
  • at least 7 years old
  • not experiencing natural menopause

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738204

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jenny Sadler, BA    617-355-7959    jenny.sadler@childrens.harvard.edu   
Contact: , BA         
Principal Investigator: Marc E Laufer, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cam Fraer, RN, BSN    617-732-4242    cfraer@partners.org   
Contact: Mary DePari, BA    617-732-4242    mdepari@partners.org   
Principal Investigator: Marc R Laufer, MD         
Sponsors and Collaborators
Children's Hospital Boston
Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Marc R Laufer, Chief, Division of Gynecology, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01738204     History of Changes
Other Study ID Numbers: IRB-P00004267
Study First Received: November 28, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
endometriosis
dysmenorrhea
pelvic pain
women's health
adolescence
biorepository
observational
gynecology
women
female

Additional relevant MeSH terms:
Dysmenorrhea
Endometriosis
Pelvic Pain
Menstruation Disturbances
Pathologic Processes
Pain
Signs and Symptoms
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014