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

NCT ID: NCT05915897

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2024-03-25

Brief Summary

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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

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Conditions

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Chronic Granulomatous Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CGD with p47phox phenotype

Specimen Donation

Intervention Type DIAGNOSTIC_TEST

blood donation

X-Linked CGD

Specimen Donation

Intervention Type DIAGNOSTIC_TEST

blood donation

Interventions

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Specimen Donation

blood donation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanguine Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sanguine BioSciences, Inc.

Woburn, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SAN-09687

Identifier Type: -

Identifier Source: org_study_id

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