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Allogeneic Hematopoietic Stem Cell Transplantation Cohort Study

NCT ID: NCT06708130

Last Updated: 2024-11-27

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

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2031-12-31

Brief Summary

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Clinical observational studies using epidemiologic theories and methods. Through the collection of various clinically relevant data, specific outcomes are evaluated in hematologic transplant patients, providing high quality real-world data for clinical practice, informing public health decision-making, and reducing the burden of disease

Detailed Description

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This is a retrospective, prospective, two-way cohort study in which clinical diagnostic and treatment data will be collected on patients enrolled in the study and followed up to characterize the natural course of the patient population as systematically as possible. All treatment decisions and clinical assessments will be made by the treating physician based on conventional treatment criteria and are not required by the study design or protocol.

The purpose of this study is to examine the natural course of the disease and current treatments. An in-depth analysis of treatment regimens and treatment duration, as well as the sequence of regimen use, will be conducted to describe treatment modalities and healthcare expenditures for this disease state. No clinical device or laboratory/assessment interventions will be conducted except for disease management requirements based on routine practice requirements or treatment monitoring based on locally approved product characterization requirements. Patients will be required to complete a separate questionnaire containing basic epidemiologic information (demographics, disease history, environmental exposure history).

During the duration of this study, some patients may be enrolled in interventional clinical trials. This is allowed and expected to occur in this study. Patients will not be required to withdraw from the cohort study and will continue to be followed up as normal, unless the investigator/patient feels it is more appropriate to withdraw from the study. All requirements of the clinical trial in question are documented according to the trial protocol.

Conditions

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Allogeneic Hematopoietic Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1

Patients who are proposed to undergo or have undergone allogeneic hematopoietic stem cell transplantation at the Stem Cell Transplant Center and Post-Transplant Medical Consortium at Regent Hospital

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. At least one visit to a stem cell transplant center beginning January 1, 2021
2. Proposed to undergo or have undergone hematopoietic stem cell transplantation

Exclusion Criteria

1. Long-term follow-up information for patients not available for any reason (e.g., unavailable or with serious concomitant disease) according to investigator opinion
2. Due to alcohol and drug addiction thus affecting their ability to follow the requirements of the study
3. Presence of conditions that could jeopardize patient safety or affect their adherence to the protocol, according to the investigator's opinion
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hu Xiaoxia

Director of the Center for Translational Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Liquan Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Shanghai Zhaxin Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xiaoxia Hu

Role: CONTACT

[email protected]
(86) 13795437259

Xiaoxia HU

Role: CONTACT

[email protected]
02164370045

Facility Contacts

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Xiaoxia Hu

Role: primary

[email protected]
(86) 13795437259

Chun Wang

Role: primary

(86) 13386259777

Chun Wang

Role: primary

(86) 13386259777

Other Identifiers

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RJ-BMT

Identifier Type: -

Identifier Source: org_study_id