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

• Sponsor: Sanguine Biosciences (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05915897
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 2.3
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Granulomatous Disease	Diagnostic Test: Specimen Donation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)
• Actual Study Start Date: May 23, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
CGD with p47phox phenotype	Diagnostic Test: Specimen Donation; blood donation
X-Linked CGD	Diagnostic Test: Specimen Donation; blood donation

Outcome Measures

Primary Outcome Measures

1. Participants have been diagnosed with Chronic Granulomatous Disease (CGD) [1 Year]

   Participants have been diagnosed with Chronic Granulomatous Disease (CGD)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanguine BioSciences, Inc.	Woburn	Massachusetts	United States	01801

Sponsors and Collaborators

• Sanguine Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanguine Biosciences
• ClinicalTrials.gov Identifier: NCT05915897
• Other Study ID Numbers: SAN-09687
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Granuloma; Granulomatous Disease, Chronic

Study Results

No Results Posted as of Jun 23, 2023