NCT06158945

Brief Summary

Sickle cell disease (SCD) refers to a group of hemoglobinopathies that include mutations in the gene encoding the beta subunit of hemoglobin. Within the umbrella of SCD, many subgroups exist, namely sickle cell anemia (SCA), hemoglobin SC disease (HbSC), and hemoglobin sickle-beta-thalassemia (beta-thalassemia positive or beta-thalassemia negative). Several other minor variants within the group of SCDs also, albeit not as common as the varieties mentioned above. It is essential to mention the sickle cell trait (HbAS), which carries a heterozygous mutation and seldom presents clinical signs or symptoms. Sickle cell anemia is the most common form of SCD

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 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

October 24, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 28, 2023

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • renal affection in sickle cell patients

    assessment of urinary endothelin 1 as a marker of renal impairment in sickle cell patients

    1 year

Interventions

urinary endothelin 1DIAGNOSTIC_TEST

assesment of endothelin 1 in urinary sample

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The patients fulfilling all the following criteria will be included: Patients with sickle cell disease in the age range of 1-18years

You may qualify if:

  • The patients fulfilling all the following criteria will be included:
  • Patients with sickle cell disease in the age range of 1-18years.

You may not qualify if:

  • Patients diagnosed to have coexistent renal disease before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Williams TN, Thein SL. Sickle Cell Anemia and Its Phenotypes. Annu Rev Genomics Hum Genet. 2018 Aug 31;19:113-147. doi: 10.1146/annurev-genom-083117-021320. Epub 2018 Apr 11.

    PMID: 29641911BACKGROUND
  • Platt OS. Sickle cell anemia as an inflammatory disease. J Clin Invest. 2000 Aug;106(3):337-8. doi: 10.1172/JCI10726. No abstract available.

    PMID: 10930436BACKGROUND
  • Lonergan GJ, Cline DB, Abbondanzo SL. Sickle cell anemia. Radiographics. 2001 Jul-Aug;21(4):971-94. doi: 10.1148/radiographics.21.4.g01jl23971.

    PMID: 11452073BACKGROUND
  • Nath KA, Katusic ZS. Vasculature and kidney complications in sickle cell disease. J Am Soc Nephrol. 2012 May;23(5):781-4. doi: 10.1681/ASN.2011101019. Epub 2012 Mar 22.

    PMID: 22440903BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Esraa A Quenawey, resident

CONTACT

Alzahraa A Ahmed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

October 24, 2023

Primary Completion

October 23, 2024

Study Completion

October 23, 2024

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations