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The Women's Health Study: From Adolescence to Adulthood (WHS:A2A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01738204
Recruitment Status : Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Marc R Laufer, Boston Children’s Hospital

Tracking Information
First Submitted Date November 28, 2012
First Posted Date November 30, 2012
Last Update Posted Date July 19, 2019
Study Start Date November 2012
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2012)
Establishing a biorepository and database [ Time Frame: next 20 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Women's Health Study: From Adolescence to Adulthood
Official Title The Women's Health Study: From Adolescence to Adulthood Sponsored by the Boston Center for Endometriosis.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
urine, saliva, blood, tissue, peritoneal fluid
Sampling Method Non-Probability Sample
Study Population clinic and community sample
Condition
  • Pelvic Pain
  • Endometriosis
  • Dysmenorrhea
  • Infertility
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 28, 2012)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2030
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: Female
Ages 7 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01738204
Other Study ID Numbers IRB-P00004267
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marc R Laufer, Boston Children’s Hospital
Study Sponsor Boston Children’s Hospital
Collaborators Brigham and Women's Hospital
Investigators
Principal Investigator: Marc R Laufer, MD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date July 2018