Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)

Terminated

• Conditions: Chronic Granulomatous Disease
• Interventions: Diagnostic Test: Specimen Donation

• Registration Number: NCT05915897
• Lead Sponsor: Sanguine Biosciences

Brief Summary

The primary study objective is to collect biospecimen samples (e.g., blood) from participants diagnosed with Chronic Granulomatous Disease (CGD). The biospecimens will be used to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• The participant is willing and able to provide written informed consent
• The participant is willing and able to provide appropriate photo identification
• Participants aged 18 to 85
• Participants have been diagnosed with Chronic Granulomatous Disease (CGD)
• Subjects who have a confirmed p47phox CGD mutation or Subjects who have a confirmed X-linked CGD mutation

Exclusion Criteria

• Participants who are pregnant or are nursing
• Participants with a known history of HIV, hepatitis, or other infectious diseases
• Participants who have taken an investigational product in the last 30 days
• Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CGD with p47phox phenotype	Specimen Donation	-
X-Linked CGD	Specimen Donation	-

Primary Outcome Measures

Name	Time	Method
Participants have been diagnosed with Chronic Granulomatous Disease (CGD)	1 Year	Participants have been diagnosed with Chronic Granulomatous Disease (CGD)

Trial Locations

Locations (1)

Sanguine BioSciences, Inc.; 🇺🇸 Woburn, Massachusetts, United States