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RecruitingNCT07930793TRACE-AAUpdated Nov 12, 2026

Aplastic Anemia Life-Course Cohort Study

An observational study in Aplastic Anemia, Clonal Hematopoiesis and Immunosuppressive Therapy, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational

From the registry’s dates

  • Started Jan 2012; still recruiting 14 years 10 months later.
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
9,999
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Anemia, Aplastic by Institute of Hematology & Blood Diseases Hospital, China — 15 open to participants now, 17 under way, none of them phase 3. Anemia, Aplastic · Institute of Hematology & Blood Diseases Hospital, China.

Started
2012
with 1 other
Observational
5 of 30
5 open now
Primary completion
2070-12
later than 16 of 16 live
Registered
30th of 30
by date

Among the 30 studies in Anemia, Aplastic by Institute of Hematology & Blood Diseases Hospital, China, this one is one of 2 that started in 2012, is one of 5 observational ones, reaches primary completion later than 16 of the 16 other live ones, and was the 30th registered.

Anemia, Aplastic

372 studies on the registry are indexed under Anemia, Aplastic; 99 are open to participants now.

Browse Anemia, Aplastic studies →

Open to participants now

15 of the 30 studies in Anemia, Aplastic by Institute of Hematology & Blood Diseases Hospital, China are open now, in 1 country. Recruiting first, the newest first:

9 more — sign in →

By country, each count listing its studies:

All 15 open studies →

Where they have run

Who these studies take

Of the 59 Anemia, Aplastic studies recruiting now, 21 (36%) set no upper age limit and 30 (51%) stop at 75 or younger; 38 take children under 18; 5 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

To establish a longitudinal cohort spanning the entire care continuum of acquired aplastic anemia (AA), from diagnosis and treatment through long-term follow-up, integrating routinely collected clinical data with biospecimens obtained in accordance with applicable ethical and regulatory requirements. The cohort will support observational studies of the natural history of AA; treatment effectiveness and safety; the evolution of clonal hematopoiesis and clonal T-cell populations; immune reconstitution following immunosuppressive therapy (IST); the incidence of platelet transfusion refractoriness and its association with response to IST; and hematopoietic and immune reconstitution after transplantation. Ultimately, the cohort aims to generate real-world evidence to inform clinical practice and reduce the burden of AA.

03

Conditions studied

  • Aplastic Anemia
  • Clonal Hematopoiesis
  • Immunosuppressive Therapy

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Keywords

  • Treatment patterns
  • Hematologic response
  • Treatment-related safety
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving immunosuppressive therapy, allogeneic hematopoietic stem cell transplantation, or other treatments in routine clinical practice will be enrolled and followed longitudinally from diagnosis through long-term follow-up.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects diagnosed with primary acquired aplastic anemia.
  • Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2012.

Exclusion criteria

Exclusion Criteria:

  • Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
  • Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
9,999 participants (estimated)
Patient registry
No

Groups and cohorts

  • TRACE-AA

    1. Describe real-world treatment patterns and clinical outcomes in AA, including IST, HSCT, and other therapies. 2. Evaluate treatment-related adverse events and safety, particularly complications of ATG/ALG-based IST and HSCT. 3. Characterize longitudinal hematopoietic and immune reconstitution after drug therapy or HSCT, including immune-cell subsets, clonal T cells, immune biomarkers, and hematopoietic recovery. 4. Estimate the cumulative incidence and trajectories of clonal hematopoiesis after IST, including cytogenetic and molecular abnormalities and PNH clones. 5. Assess prognosis, including treatment discontinuation, relapse, clonal evolution, quality of life, and long-term survival.

    Other: A combined retrospective and prospective observational follow-up

Interventions

  • OtherA combined retrospective and prospective observational follow-up

    Data collected will include: demographic characteristics; medical history and environmental exposures; comorbidities and concomitant medications; medical records; treatment regimens; treatment-related adverse events; treatment outcomes; clonal hematopoiesis and clonal evolution; immune reconstitution; platelet transfusion refractoriness; clonal T-cell populations; quality of life; and health economic outcomes, including healthcare costs and length of hospital stay.

06

What researchers measure

Primary outcomes

  1. Hematologic response

    Hematologic response contains improvements in hemoglobin level, platelet count and neutrophil count.

    Time frame: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.

  2. Clonal evolution

    Progression to paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, or acute myeloid leukemia.

    Time frame: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.

  3. Treatment related adverse events

    The main treatment modalities include allogeneic hematopoietic stem cell transplantation (allo-HSCT) and intensive immunosuppressive therapy (IST). Use Common Terminology Criteria for Adverse Events (CTCAE) Version 6 to assess the adverse event

    Time frame: Within 10 years after allo-HSCT; within 6 months after IST

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2012 (actual). Primary completion is estimated for Dec 2070, 707 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartActual
Jan 1, 2012
Primary completionEst.
Dec 31, 2070
CompletionEst.
Dec 31, 2070
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07930793
Responsible party
Jun Shi (Director of the Red Blood Cell Diseases Center & Regenerative Medicine Clinic, Institute of Hematology & Blood Diseases Hospital, China) — Principal investigator
First posted
Nov 12, 2026
Start date
Jan 1, 2012
Primary completion
Dec 31, 2070 (estimated)
Completion
Dec 31, 2070 (estimated)
Last update
Nov 12, 2026

Study contacts

Jun Shi, PhD
Contact
shijun@ihcams.ac.cn
13752253515
Jingyu Zhao, MPH
Contact
zhaojingyu@ihcams.ac.cn
13752253515
Jun Shi, PhD
principal investigator · Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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