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Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma

Sponsor
University of Electronic Science and Technology of China (Other)
Overall Status
Unknown status
CT.gov ID
NCT03167476
Collaborator
Chengdu Nuoen Biotechnologies, Inc. (Other), Sichuan Cancer Hospital & Institute (Other)
200
Enrollment
1
Location
28
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives are to:

  1. validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.

  2. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.

  3. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

The objectives are to:

  1. validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.

  2. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.

  3. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

This trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. The investigators will develop panels of miRNAs that are specific biomarkers of lymphoma, and assist clinical outcomes with these miRNAs.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma
    Actual Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    RLH

    This group includes subjects diagnosed with reactive lymphoid hyperplasia.
    Lymphoma

    This group includes subjects diagnosed with lymphoma.

    Outcome Measures

    Primary Outcome Measures

    1. The concentration of miRNA expression quantitated in absolute copy numbers and their correlation in patients with reactive hyperplasia and lymphoma. [Three years]

      The concentration of tissue miRNAs in absolute quantification in comparison to reactive hyperplasia and lymphoma. To investigate the potential prognosis of lymphoma by the expression difference of the miRNA panel. Sensitivity, specificity and the potential scopes of selected miRNA in the miRNA panel to distinguish hyperplasia and lymphoma and against standard clinical outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults 18 years and above

    • Has condition related to lymphoma or reactive lymphoid hyperplasia

    Exclusion Criteria:

    • Age below 18 years

    • Known pregnancy

    • lymph tissue cannot be accessed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Electronic Science and Technology of China Chengdu Sichuan China 610054

    Sponsors and Collaborators

    • University of Electronic Science and Technology of China
    • Chengdu Nuoen Biotechnologies, Inc.
    • Sichuan Cancer Hospital & Institute

    Investigators

    • Study Director: Jian Huang, PhD, University of Electronic Science and Technology of China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Electronic Science and Technology of China
    ClinicalTrials.gov Identifier:
    NCT03167476
    Other Study ID Numbers:
    • Uestc502
    First Posted:
    May 30, 2017
    Last Update Posted:
    May 30, 2017
    Last Verified:
    Aug 1, 2016
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Electronic Science and Technology of China
    miRNA
    biomarker
    Additional relevant MeSH terms:
    Lymphoma
    Pseudolymphoma
    Hyperplasia

    Study Results

    No Results Posted as of May 30, 2017