US National Institute starts Data Collection Study of Pediatric and Adolescent Gynecology Conditions
Photo by Edvin Johansson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is conducting the clinical trial Data Collection Study of Pediatric and Adolescent Gynecology Conditions.
It is planned to include 11000 participants.
Actual study start date is January 27, 2021. The researchers expect to complete the study by December 2, 2039.
This data collection protocol is designed to allow data and specimen collection of individuals with pediatric and adolescent gynecology (PAG) conditions such as: reproductive, endocrine, gynecologic tumors and skin conditions, menstrual abnormalities and congenital anomalies of the reproductive tract. Adults and children with pediatric and adolescent gynecology-related condition(s) may be enrolled under this protocol to collect clinical data and specimen for secondary review and analysis and to provide stimuli for new clinical research initiatives.
One primary outcome measure is to create a large database of PAG conditions in presentation and variety.
The population that can be enrolled into this study includes pediatric and adolescent patients with gynecologic conditions and their family members that would provide clinical information related to the diagnosis of a proband.
There are a number of conditions that do not allow participation, such as: any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient, will exclude participation. Patients who are critically ill, unstable, or with severe organ failure that may affect/limit the evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded.
The study will take place at the National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is one of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. It supports and conducts research aimed at improving the health of children, adults, families, and communities, including: Reducing infant deaths, Promoting healthy pregnancy and childbirth, Investigating growth and human development, Examining problems of birth defects and intellectual and developmental disabilities, Understanding reproductive health and Enhancing function across the lifespan through rehabilitation research.
Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT04717349
