NCT04924686

Brief Summary

Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

3.1 years

First QC Date

June 7, 2021

Last Update Submit

June 10, 2021

Conditions

Keywords

NOD2 ligands

Outcome Measures

Primary Outcomes (1)

  • NOD2 ligands in fecal and plasma

    detected using targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters

    baseline

Study Arms (5)

Crohn's disease

The fecal and plasma were collected

Other: Observational studies, no intervention

Ulcerative colitis

The fecal and plasma were collected

Other: Observational studies, no intervention

Diabetes mellitus, type 2

The fecal and plasma were collected

Other: Observational studies, no intervention

Atherosclerotic cardiovascular disease

The fecal and plasma were collected

Other: Observational studies, no intervention

Colorectal cancer

The fecal and plasma were collected

Other: Observational studies, no intervention

Interventions

Observational studies, no intervention

Atherosclerotic cardiovascular diseaseColorectal cancerCrohn's diseaseDiabetes mellitus, type 2Ulcerative colitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with IBD, CRC, ACVD or DM2 hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled

You may qualify if:

  • Males or females at least 18-70 years old.
  • Patient able to give informed consent.
  • Patient with biopsy-proven CRC
  • Patient with biopsy-proven Crohn's disease (CD) or ulcerative colitis(UC), in the active phase.
  • patients with clinical diagnosed DM2
  • patients with ACVD:coronary angiography more than 50% stenosis in single or multiple vessels.
  • The age- and sex- matched health controls for each patient.

You may not qualify if:

  • Use antibiotics or probiotics within the last 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Philpott DJ, Sorbara MT, Robertson SJ, Croitoru K, Girardin SE. NOD proteins: regulators of inflammation in health and disease. Nat Rev Immunol. 2014 Jan;14(1):9-23. doi: 10.1038/nri3565. Epub 2013 Dec 13.

    PMID: 24336102BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fecal, Plasma

MeSH Terms

Conditions

Colorectal NeoplasmsInflammatory Bowel DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGastroenteritisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hongwei Zhou, professor

    Zhujiang Hospital, Guangzhou, Guangdong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Gao, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 14, 2021

Study Start

May 10, 2020

Primary Completion

June 10, 2023

Study Completion

August 15, 2023

Last Updated

June 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations