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NCT05355675
The Association of Microbiota Composition With cGVHD After Allo-HSCT
trial testing blood sample in Hematopoietic Stem Cell Transplantation in 300 participants. Status unknown.
1 May 2025
Quick facts
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 May 2022 |
| Primary completion | 1 May 2025 |
| Estimated completion | 31 May 2025 |
| Sites | 10 locations across China |
Drugs / interventions tested
- blood sample — full drug profile →
- stool sample — full drug profile →
Conditions studied
- Hematopoietic Stem Cell Transplantation — all drugs for Hematopoietic Stem Cell Transplantation →
- Hematologic Malignancy — all drugs for Hematologic Malignancy →
- Chronic Graft-versus-host-disease — all drugs for Chronic Graft-versus-host-disease →
- Complication — all drugs for Complication →
Sponsor
First Affiliated Hospital of Zhejiang University
Who can join
Adults 18 to 65, any sex, with Hematopoietic Stem Cell Transplantation or Hematologic Malignancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Previous studies had found that the microbe in intestinal after allogeneic hematopoietic cell transplantation(allo-HSCT) were closely associated with overall survival and post-transplantation complications, especially graft versus host disease (GVHD).Due to the limited data on the association of microbiota composition with chronic GVHD(cGVHD) after allogeneic hematopoietic stem cell transplantation, the relationship between microbiota composition and post-transplantation complications, especially cGVHD, needs to be further evaluated.Detailed studies of the microbiome and host immune system will lead to the discovery of microbiome markers for early identification of patients at high risk for cGVHD. This may regulate patients' gut microbiota in an individualized manner to achieve optimal treatment outcomes while avoiding severe post-transplant cGVHD. We will operate a prospective, multicenter, nonrandomized, observational study. Patients will be asked to provide blood and stool samples during allo-HSCT.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05355675 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Zhejiang University
- Last refreshed: 2 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05355675.
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