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Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03117036
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : November 27, 2023
Sponsor:
Collaborator:
Samsung Genomic Institute
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Drug: Chemotherapy

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective Study for Patients With Lymphoid Malignancy at the Samsung Medical Center
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 28, 2024
Estimated Study Completion Date : December 28, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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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 Name: Treatment


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 3 months after chemotherapy ]
    response to chemotherapy


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 year ]
    Time to relapse/progression or any kinds of death

  2. Overall survival [ Time Frame: 3 year ]
    Time to any kinds of death

  3. Biomarker [ Time Frame: 3 year ]
    Development of biomarker predicting response and survival outcome


Biospecimen Retention:   Samples With DNA
serum and cell-free DNA from patients' peripheral blood

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117036


Contacts
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Contact: Seok Jin Kim, MD, PhD +82234101766 kstwoh@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Seok Jin Kim, MD, PhD    82-2-3410-1766    kstwoh@skku.edu   
Principal Investigator: Seok Jin Kim, MD, PhD         
Sub-Investigator: Won Seog Kim, MD, PhD         
Sub-Investigator: Sivia Park, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Samsung Genomic Institute
Investigators
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Principal Investigator: Seok Jin Kim, MD, PhD Samsung Medical Center
More Information
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Additional Information:

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03117036    
Other Study ID Numbers: 2016-11-040
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: November 27, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
lymphoma
cohort
serum
cell-free DNA
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases