Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III

November 22, 2023 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seok Jin Kim, MD, PhD
  • Phone Number: +82234101766
  • Email: kstwoh@skku.edu

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Seok Jin Kim, MD, PhD
        • Sub-Investigator:
          • Won Seog Kim, MD, PhD
        • Sub-Investigator:
          • Sivia Park, MD, PhD
        • Contact:
          • Seok Jin Kim, MD, PhD
          • Phone Number: 82-2-3410-1766
          • Email: kstwoh@skku.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphoma. All patients should receive systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lymphoma
Patients are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphoma. All patients should receive systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled.
Drug: Chemotherapy
Systemic chemotherapy with curative intent
Other Names:
  • Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 3 months after chemotherapy
response to chemotherapy
3 months after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 year
Time to relapse/progression or any kinds of death
3 year
Overall survival
Time Frame: 3 year
Time to any kinds of death
3 year
Biomarker
Time Frame: 3 year
Development of biomarker predicting response and survival outcome
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Samsung Genomic Institute

Investigators

  • Principal Investigator: Seok Jin Kim, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Estimated)

December 28, 2024

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-11-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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