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The Women's Health Study: From Adolescence to Adulthood

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ClinicalTrials.gov Identifier: NCT01738204
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Pelvic Pain Endometriosis Dysmenorrhea Infertility

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
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.
Study Start Date : November 2012
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Establishing a biorepository and database [ Time Frame: next 20 years ]

Biospecimen Retention:   Samples With DNA
urine, saliva, blood, tissue, peritoneal fluid

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738204


Contacts
Contact: Jenny Sadler, MPH 617-355-7959 jenny.sadler@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jenny Sadler, MPH    617-355-7959    womenshealthstudy@childrens.harvard.edu   
Principal Investigator: Marc R Laufer, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cam Fraer, RN, BSN    617-732-4242    womenshealthstudy@partners.org   
Principal Investigator: Marc R Laufer, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Marc R Laufer, MD Boston Children’s Hospital
More Information

Additional Information:
Responsible Party: Marc R Laufer, Chief, Division of Gynecology, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01738204     History of Changes
Other Study ID Numbers: IRB-P00004267
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Marc R Laufer, Boston Children's Hospital:
dysmenorrhea
endometriosis
pelvic pain
women's health
adolescence
biorepository
observational
women
female
gynecology
fertility
infertility

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