Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn's Disease

Award Number: U01DK134356
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

Group Awards By:

View Award Description

Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn's Disease - PROJECT SUMMARY/ABSTRACT Therapeutic goals in pediatric Crohn's Disease (CD) have shifted from clinical improvement or remission to endoscopic healing (EH) by ileocolonoscopy and transmural healing (TH) by magnetic resonance enterography (MRE). Patients achieving complete healing (CH, EH and TH) experience fewer hospitalizations or surgery. We hypothesize that specific pre-treatment clinical, radiologic, transcriptomic, genomic, and microbial factors along with attainment of targeted anti-TNF biologic exposure will be associated with the primary endpoint, CH, and the major secondary endpoints, EH and TH, 52 weeks after anti-TNF start. We will test this hypothesis in a prospective cohort study of 550 newly diagnosed pediatric-onset CD subjects treated with anti-TNF medication within 6 months of diagnosis guided by therapeutic drug monitoring (TDM). Aim 1. Evaluate putative associations and explore novel associations between CH and baseline measures of clinical and radiologic severity. We hypothesize that pre-treatment nutritional status, antimicrobial serologies, and MRE findings will be associated with year 1 CH. Formal hypothesis tests will be carried out with appropriately controlled Type I error probabilities to confirm the predictive power of a set of pre- specified baseline measures using a logistic regression model based on the year 1 CH outcome. Aim 2. Evaluate putative associations and explore novel associations between anti-TNF drug levels, CH, and host and microbial genomic and transcriptomic factors. We hypothesize that pre-treatment gene expression signatures and microbial factors will be associated with early anti-TNF drug levels and year 1 CH. We will characterize the host genotype, baseline mucosal and longitudinal fecal microbial taxonomic profile, and baseline ileal and colon host transcriptome. Those variables identified as significantly associated will be candidates for the final prediction model determined in Aim 3. Aim 3. Use a k-fold cross-validation procedure to determine the optimal predictive model of year 1 CH. We hypothesize that a model which includes host gene signatures and microbes will improve prediction of CH beyond one based on clinical and imaging factors alone. The model will include clinical and imaging predictors from Aim 1 and host and microbial characteristics found to be potentially explanatory in Aim 2. Impact. The proposed inception cohort study, CAMEO, will provide a robust platform to study factors that contribute to healing in pediatric CD that can then be translated into practice, as well as guiding future therapies targeting the host immune response and microbiota in patients unlikely to achieve healing. .


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $2,900,000 )
2025	2025	CONNECTICUT CHILDREN'S MEDICAL CENTER	282 WASHINGTON ST	HARTFORD	CT	06106	CAPITOL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/1/2025	NON-COMPETING CONTINUATION	$2,900,000
														Subtotal = $2,900,000

Issue Date FY: 2024 ( Subtotal = $2,701,767 )
2024	2024	CONNECTICUT CHILDREN'S MEDICAL CENTER	282 WASHINGTON ST	HARTFORD	CT	06106	CAPITOL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/7/2024	NON-COMPETING CONTINUATION	$168,861
2024	2024	CONNECTICUT CHILDREN'S MEDICAL CENTER	282 WASHINGTON ST	HARTFORD	CT	06106	CAPITOL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	4/8/2024	NON-COMPETING CONTINUATION	$2,532,906
														Subtotal = $2,701,767

Issue Date FY: 2023 ( Subtotal = $2,799,999 )
2023	2023	CONNECTICUT CHILDREN'S MEDICAL CENTER	282 WASHINGTON ST	HARTFORD	CT	06106	CAPITOL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/30/2023	NEW	$2,799,999
2023	2023	CONNECTICUT CHILDREN'S MEDICAL CENTER	282 WASHINGTON ST	HARTFORD	CT	06106	CAPITOL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	4/7/2023	NEW	$0
														Subtotal = $2,799,999

Grand Total All Awards = $8,401,766

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn's Disease

Award Number: U01DK134356

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer