Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02933411
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-04-11
First Post:
2016-10-10
Brief Title:
Low VW Activity in Adolescent HMB
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Genotypic and Phenotypic Analysis of Adolescents With Heavy Menstrual Bleeding and Low Von Willebrand Activity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Low VWF
Brief Summary:
This is a research study for patients diagnosed with heavy menstrual bleeding HMB and low Von Willebrand Factor VWF Menstruation also known as a period is the regular discharge of blood and tissues from the uterus HMB is having a heavier amount of discharge during menstrual period Low Von Willebrand Factor means that the participant has lower level of a blood protein that is important for clotting of blood and so the participant is at a higher risk for bleeding
The purpose of this project is to study the genetic differences of adolescent females with HMB and low VWF activity and compare the genetic differences with their bleeding manifestations response to medications and outcome
The purpose of this project is to study the genetic differences of adolescent females with HMB and low VWF activity and compare the genetic differences with their bleeding manifestations response to medications and outcome
Detailed Description:
One hundred and twenty subjects will be enrolled Adolescent females with heavy menstrual bleeding HMB and low Von Willebrand Factor VWF will be recruited
Data collection will occur from participants medical records in regards to their low VWF activity and HMB medical history
Participants will be asked to complete symptom questionnaires in regards to their HMB
A blood sample will be collected to analyze how many participants have the disease causing sequence variation in the VWF gene and other genes affecting bleeding clotting and blood vessel biology and correlated with their bleeding history
The blood sample will be deidentified and stored indefinitely for future research
Data collection will occur from participants medical records in regards to their low VWF activity and HMB medical history
Participants will be asked to complete symptom questionnaires in regards to their HMB
A blood sample will be collected to analyze how many participants have the disease causing sequence variation in the VWF gene and other genes affecting bleeding clotting and blood vessel biology and correlated with their bleeding history
The blood sample will be deidentified and stored indefinitely for future research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None