U54HL178351

Include Down Syndrome Clinical Cohort Coordinating Center (DS-4C) - Project Summary/Abstract

The overarching goal of the proposed Include Clinical Cohort Coordinating Center (DS-4C), co-led by investigators at RTI International and Emory University, is to improve the health and well-being of individuals with Down Syndrome (DS) by supporting the Include Project’s DS Cohort Development Program (DS-CDP).

In this capacity, the DS-4C will serve as the central hub for orchestrating and integrating all components of the DS-CDP, including overseeing the development and implementation of a common protocol to guide harmonized data collection across multiple DS Cohort Research Sites (DS-CRS) in the DS-CDP and facilitating data transfer into the Include Data Coordinating Center (DCC) and data hub for availability to researchers.

The complex structure of the DS-CDP requires the DS-4C’s expert leadership and coordination to generate an effective, integrated, unified network to achieve the goal of generating deep phenotyping data and collecting biospecimens in a large, diverse cohort of individuals with DS across the lifespan to support future research efforts to improve DS-associated co-morbidities.

The four cores of the DS-4C (Administrative, Cohort, Outreach, and Data Management) will leverage the expertise of core staff and work collaboratively to provide administrative support to facilitate collaboration and communication across the DS-CDP; ensure seamless implementation of the protocol; implement and support inclusive outreach efforts to facilitate inclusion and representation in recruitment; and manage the flow of data and biospecimens from the DS-CRS to the Include DCC and data hub and DS-biorepository, respectively.

Our specific aims are as follows:

Aim 1: Implement tools and systems to foster seamless integration and operational efficiency within the DS-4C and across the DS-CDP.

Aim 2: Provide expertise and resources to develop and implement the common protocol across the DS-CDP while enhancing the scientific rigor of DS-CRS studies to maximize the scientific impact of the Include Project.

Aim 3: Enhance community engagement, facilitate recruitment of participants and team members from typically underrepresented groups, advance health equity goals, and promote awareness of the Include Program.

Aim 4: Manage the flow of data from DS-CRS into the Include DCC and data hub for access by the DS research community.

The DS-4C will be led by multiple principal investigators, Dr. Hunter at RTI and Dr. Rosser at Emory, with a collaborative history and extensive expertise in elucidating health outcomes of individuals with DS through phenotypic protocol development, biospecimen collection, multi-site recruitment efforts, and data harmonization.

The proposed DS-4C is immediately and amply prepared to support its mission to develop clinically meaningful findings that positively impact those affected by DS.

Research Triangle Institute

TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.310 - Trans-NIH Research Support

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Research Triangle Park, North Carolina 277092194 United States

Single Zip Code

Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) (U54 Clinical Trial Not Allowed) (RFA-OD-24-005)

Amendment Since initial award the total obligations have increased 198% from $1,999,508 to $5,956,261.