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Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03117036
Collaborator
Samsung Genomic Institute (Other)
600
Enrollment
1
Location
83.9
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Study for Patients With Lymphoid Malignancy at the Samsung Medical Center
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [3 months after chemotherapy]

      response to chemotherapy

    Secondary Outcome Measures

    1. Progression-free survival [3 year]

      Time to relapse/progression or any kinds of death

    2. Overall survival [3 year]

      Time to any kinds of death

    3. Biomarker [3 year]

      Development of biomarker predicting response and survival outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center
    • Samsung Genomic Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT03117036
    Other Study ID Numbers:
    • 2016-11-040
    First Posted:
    Apr 17, 2017
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Hodgkin Disease

    Study Results

    No Results Posted as of May 9, 2022