Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome

NCT02330692 | Unknown

• 1 other identifier: 4-2013-0479
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• the number of patients with MDS to examine new prognostic factors

  10 years

Interventions

No intervention OTHER

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with MDS in Severance Hospital. All patients are eligible for study occuring from the starting day of the study. Patients are enrolled if the written consent are acquired. Considering the annual incidence rate of the disease, target patient population is 1,000 people during the study period.

You may qualify if:

• MDS diagnosed by bone marrow aspiration and biopsy at Severance Hospital.
• Male and Female over 16 years of age. ③ Written consent of the patient to participate in the cohort ④ Deaths during the study period are waiver of consent

You may not qualify if:

• ① Refusal or trouble understanding the written consent

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Acquisition and storage of blood and bone marrow samples at diagnosis, at response evaluation and at times of relapse or refractory period.

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2014
• First Posted: January 5, 2015
• Study Start: September 1, 2013
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

KR (1)