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The Women's Health Study: From Adolescence to Adulthood
This study is currently recruiting participants.
Verified June 2017 by Marc R Laufer, Boston Children's Hospital
Sponsor:
Boston Children’s Hospital
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Marc R Laufer, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01738204
First received: November 28, 2012
Last updated: June 21, 2017
Last verified: June 2017
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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 Infertility |
| 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 Marc R Laufer, Boston Children's Hospital:
Primary Outcome Measures:
- Establishing a biorepository and database [ Time Frame: next 20 years ]
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 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | November 28, 2012 |
| Last Updated: | June 21, 2017 |
Keywords provided by Marc R Laufer, Boston Children's Hospital:
|
endometriosis dysmenorrhea pelvic pain women's health adolescence biorepository |
observational women female gynecology fertility infertility |
Additional relevant MeSH terms:
|
Infertility Endometriosis Pelvic Pain Dysmenorrhea Genital Diseases, Male Genital Diseases, Female |
Pain Neurologic Manifestations Signs and Symptoms Menstruation Disturbances Pathologic Processes |
ClinicalTrials.gov processed this record on August 22, 2017