Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03167476
Recruitment Status : Unknown
Verified August 2016 by University of Electronic Science and Technology of China.
Recruitment status was:  Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Chengdu Nuoen Biotechnologies, Inc.
Sichuan Cancer Hospital & Institute
Information provided by (Responsible Party):
University of Electronic Science and Technology of China

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
Lymphoma Hyperplasia Lymphoid Reactive

Layout table for study information
Study Type : Observational
Estimated 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 : August 1, 2016
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
RLH
This group includes subjects diagnosed with reactive lymphoid hyperplasia.
Lymphoma
This group includes subjects diagnosed with lymphoma.



Primary Outcome Measures :
  1. The concentration of miRNA expression quantitated in absolute copy numbers and their correlation in patients with reactive hyperplasia and lymphoma. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This research project will recruit a cohort of observational lymphoma patients. Diagnosis and immunophenotyping should be performed on FFPE tissues according to the WHO-classification system and reviewed by an in-house pathologist. Reactive hyperplasia controls will also be recruited to demonstrate the physiological level of different body-tissue miRNAs.
Criteria

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

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): NCT03167476


Contacts
Layout table for location contacts
Contact: Juanjuan Kang + 86-28-83202351 kjj@immunet.cn

Locations
Layout table for location information
China, Sichuan
University of Electronic Science and Technology of China Recruiting
Chengdu, Sichuan, China, 610054
Contact: Huang Jian, Ph.D    + 86-28-83202351    hj@uestc.edu.cn   
Sponsors and Collaborators
University of Electronic Science and Technology of China
Chengdu Nuoen Biotechnologies, Inc.
Sichuan Cancer Hospital & Institute
Investigators
Layout table for investigator information
Study Director: Jian Huang, PhD University of Electronic Science and Technology of China

Layout table for additonal information
Responsible Party: University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT03167476    
Other Study ID Numbers: Uestc502
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: August 2016

Layout table for additional information
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:
Layout table for MeSH terms
Lymphoma
Pseudolymphoma
Hyperplasia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes