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

NCT05915897 | Terminated

• 1 other identifier: SAN-09687
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Granulomatous Disease

Outcome Measures

Primary Outcomes (1)

• Participants have been diagnosed with Chronic Granulomatous Disease (CGD)

  Participants have been diagnosed with Chronic Granulomatous Disease (CGD)

  1 Year

Study Arms (2)

CGD with p47phox phenotype

Diagnostic Test: Specimen Donation

X-Linked CGD

Diagnostic Test: Specimen Donation

Interventions

Specimen Donation DIAGNOSTIC_TEST

blood donation

CGD with p47phox phenotype; X-Linked CGD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants have been diagnosed with Chronic Granulomatous Disease (CGD)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanguine Biosciences: lead

Study Sites (1)

Sanguine BioSciences, Inc.

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Conditions

Granulomatous Disease, Chronic

Condition Hierarchy (Ancestors)

Phagocyte Bactericidal Dysfunction; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: May 23, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (1)