NCT04814394

Brief Summary

we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Apr 2022

Longer than P75 for all trials

Status
not yet recruiting

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 Progress88%
Apr 2022Dec 2026

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

March 22, 2021

Last Update Submit

October 22, 2021

Conditions

Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (1)

  • The proportion of circulating T-follicular helper and T-follicular regulatory in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after treatment

    Baseline

Secondary Outcomes (1)

  • Measure the ratio between the T- follicular helper and T-follicular regulatory

    Baseline

Interventions

flowcytometryDIAGNOSTIC_TEST

The study of CD4,CD25,FOXP3 and PD-1 on peripheral blood sample

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample size is 50 (25 in each arm) but number of controls will be decreased and number of cases will be increased

You may qualify if:

  • Patients diagnosed as autoimmune hemolytic anemia, primary or secondary, male or female, any age but not on treatment

You may not qualify if:

  • Pregnancy or breast-feeding women
  • Patients treated with corticoids or immunosuppressant.
  • Patients with hematological malignance.
  • Patients with alloimmune hemolytic anemia as ABO incompatibility or transplant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

April 1, 2022

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 1, 2026

Last Updated

October 26, 2021

Record last verified: 2021-10