임상연구정보서비스

Search: Search

Cohort for biomarkers to predict prognosis and treatment response in acute leukemia

Status Approved

First Submitted Date

2017/02/01
Registered Date

2017/03/10
Last Updated Date

2020/08/10

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002261
Unique Protocol ID	KC16TISI0438
Public/Brief Title	Cohort for biomarkers to predict prognosis and treatment response in acute leukemia
Scientific Title	Cohort for biomarkers to predict prognosis and treatment response in acute leukemia
Acronym	Pre-cohort AML
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC16TISI0438
Approval Date	2016-07-08
Institutional Review Board Name	The Catholic University of Korea, Seoul St. Mary's Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hee-Je Kim
Title	Professor
Telephone	+82-2-2258-6039
Affiliation	The Catholic University of Korea
Address	222 Banpo-daero, seocho-gu, seoul
Contact Person for Public Queries
Name	Young-woo Jeon
Title	Clinical associate p
Telephone	+82-2-2258-6038
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 Banpo-daero, seocho-gu, seoul
Contact Person for Updating Information
Name	Young-woo Jeon
Title	Clinical associate p
Telephone	+82-2-2258-6038
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 Banpo-daero, seocho-gu, seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-07-08 Actual
Target Number of Participant	1500
Primary Completion Date	2025-12-31 , Anticipated
Study Completion Date	2025-12-31 , Anticipated
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-07-08 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute
Project ID	KC16TISI0438

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Under the treatment of acute leukaemia, which is based on the classification of acute leukaemia in the treatment of acute leukemia, adapted is now considered a major treatment strategy. In order to achieve these things, chromosome and molecular cell abnormalities are essential, and the need for further reporting and validation of other additional biomakers is necessary, considering that acute leukaemia has a highly diverse pathophysiological mechanisms. In addition, for the implantation of hematopoietic stem cell transplants, the need for transplant transplants and associated biological markers to monitor post-transplant immunologic remodeling is necessary to minimize the risk of transplant complications and reduce the transplantaion-related death. Thus, at time points of initial diagnosis and adaptation of each therapeutic modalities, prospective clinical data and samples will help for analysing of probable cell, proteins, chromsome (DNA, RNA, miRNA, etc) as prognostic biomarkers. The objective of this study is to establish a cohort for discovering the prognosis for acute leukaemia patients for acute leukaemia patients and stratification, which will be explored by research and development.

Study Summary Information

Lay Summary

Under the treatment of acute leukaemia, which is based on the classification of acute leukaemia in the treatment of acute leukemia, adapted is now considered a major treatment strategy. In order to achieve these things, chromosome and molecular cell abnormalities are essential, and the need for further reporting and validation of other additional biomakers is necessary, considering that acute leukaemia has a highly diverse pathophysiological mechanisms. In addition, for the implantation of hematopoietic stem cell transplants, the need for transplant transplants and associated biological markers to monitor post-transplant immunologic remodeling is necessary to minimize the risk of transplant complications and reduce the transplantaion-related death. Thus, at time points of initial diagnosis and adaptation of each therapeutic modalities, prospective clinical data and samples will help for analysing of probable cell, proteins, chromsome (DNA, RNA, miRNA, etc) as prognostic biomarkers. 
The objective of this study is to establish a cohort for discovering the prognosis for acute leukaemia patients for acute leukaemia patients and stratification, which will be explored by research and development.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Others
Target Number of Participant	1500
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Patient group
Cohort/ Group 1	Cohort/Group Description A group of patients who have been received a allogeneic hematopoietic stem cell transplantation for AML: the acquisition of Bone marrow aspirate and serum blood at diagnosis and follow-up period
Cohort/ Group 2	Cohort/Group Label Heathy donor group
Cohort/ Group 2	Cohort/Group Description a group of healthy donor have been given a donation of bone marrow cells: the acquisition of Bone marrow aspirate and serum blood at once
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample with DNA
Biospecimen Description	1) patient group: serum, blood cell. bone marrow aspirate, epithelial cells by buccal swap ( or hair ) 2) healthy donor group: serum, blood cells, bone marrow aspirate

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	1) patient group: patients with suspected acute leukemia or confirmation of aacute leukemia. 2) healthy donor group: healthy donor who donated with bone marrow cells
Sampling Method	Because this study is to establish the cohort about patients newly diagnosed with AML prospectively and analysis the retrospective data by using the electronic medical record, It does not calculate the sample size on the basis of statistical power. In step 2, based on our center’s historical data ( 170~250 patients/year), all about 1,500 patients who fit with inclusion criteria will register and analysis for 5 years.
Condition(s)/Problem(s)	(D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description 1) patient group ① step 1: adult with over 18-year-old, patients who confirmed of acute leukemia by WHO classification, patients who can be checked the electronic medical record ② step 2: adult with over 18-year-old, patients who suspected of acute leukemiaL, and then confirmed with bone marrow apsirate by WHO classification, Patients with voluntary informed consent about blood and bone marrow sampling. 2) healthy donor group : among the all hematopoietic stem cell donors, healthy donor who donated with bone marrow cells
Exclusion Criteria	patients who not finally confirmed of acute leukemia by WHO classification
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Characteristics of patient and leukemia at diagnosis, type of chemotherapy, chemotherapy response, hematopoietic stem cell transplantation and related-survival rate, incidence of HSCT-related complications
Timepoint	Batch analysis after completion of study
Secondary Outcome(s) 1
Outcome	Promising biomarker determination
Timepoint	Batch analysis after completion of study

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

Move list page Move to top