Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Prospective Study for Patients With Lymphoid Malignancy at the Samsung Medical Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117036
• Other study ID #: 2016-11-040
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: December 28, 2026

Study information

• Verified date: November 2023
• Source: Samsung Medical Center
• Contact: Seok Jin Kim, MD, PhD
• Phone: +82234101766
• Email: kstwoh[@]skku.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This prospective study enrolls patients who are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphomas. Enrolled patients will be treated according to our institution' treatment policy in clinical practice. The disease status including response to therapy and survival status will be regularly updated during the study period. Patients' serum and cell-free DNA will be collected and analyzed.

Description:

The study population is aggressive lymphomas requiring systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled into the study. Patients can be treated according to the principle of routine care of our institute. The study process is as follows.

1. Registration after informed consent.

2. Laboratory and radiological evaluation after registration including collection of serum and cell-free DNA from patients' peripheral blood

3. Interim and final response evaluation including collection of serum and cell-free DNA from patients' peripheral blood

4. Regular monitoring disease status and update of survival status

5. Laboratory and radiological evaluation after relapse or progression including collection of serum and cell-free DNA from patients' peripheral blood

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 28, 2026
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Pathologically diagnosed Hodgkin and non-Hodgkin lymphomas

2. 20 years

3. Patients requiring systemic chemotherapy with curative intent

4. Written informed consent

Exclusion Criteria:

1. Myeloid malignancy

2. Multiple myeloma

3. Patients do not require systemic chemotherapy with curative intent

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Hodgkin
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Chemotherapy
Systemic chemotherapy with curative intent

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Samsung Genomic Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	response to chemotherapy	3 months after chemotherapy
Secondary	Progression-free survival	Time to relapse/progression or any kinds of death	3 year
Secondary	Overall survival	Time to any kinds of death	3 year
Secondary	Biomarker	Development of biomarker predicting response and survival outcome	3 year