The Women's Health Study: From Adolescence to Adulthood
This study is currently recruiting participants.
Verified November 2012 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
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: NA
Last verified: November 2012
History: No changes posted
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Purpose
The Boston Center for Endometriosis is establishing the first comprehensive database and biorepository devoted to endometriosis in both adolescents and adults. Females with endometriosis and healthy female volunteers ages 7+ years may volunteer to provide biological samples (urine and saliva; option to provide blood) for the biorepository, as well as to provide some general health information. These biological samples will used by scientific researchers to investigate the causes of endometriosis, to discover new diagnostic tools and treatments, and to hopefully lead to a cure for this chronic, debilitating disease.
| Condition |
|---|
|
Endometriosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Boston Center for Endometriosis: A Cross-Institutional Biorepository and Database |
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
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: Porsha Eden, BA 617-355-3309 porsha.eden@childrens.harvard.edu | |
| Contact: Jenny Sadler, BA 617-355-7959 jenny.sadler@childrens.harvard.edu | |
| 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: | November 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
endometriosis dysmenorrhea pelvic pain women's health |
adolescence biorepository observational non-interventional |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013