NCT06708130

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
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 Progress47%
May 2021Dec 2031

Study Start

First participant enrolled

May 1, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

10.7 years

First QC Date

November 13, 2024

Last Update Submit

November 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS since enrollment

    Time Frame: through study completion, an average of 5 year

Secondary Outcomes (7)

  • Strictly complete remission (sCR)

    Time Frame: through study completion, an average of 5 year

  • Complete remission (CR)

    Time Frame: through study completion, an average of 5 year

  • Very Good Partial Relief (VGPR)

    Time Frame: through study completion, an average of 5 year

  • Partial remission (PR)

    Time Frame: through study completion, an average of 5 year

  • Minor Relief (MR)

    Time Frame: through study completion, an average of 5 year

  • +2 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

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

Patients who are proposed to undergo or have undergone allogeneic hematopoietic stem cell transplantation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Liquan Hospital

Shanghai, China

NOT YET RECRUITING

Shanghai Zhaxin Hospital

Shanghai, China

NOT YET RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Center for Translational Medicine

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 27, 2024

Study Start

May 1, 2021

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations