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

NCT03167476 | Unknown

• 1 other identifier: Uestc502
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives are to:

1. 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. 2.investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
3. 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.
4. 4.validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
5. 5.investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
6. 6.investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

Conditions

Lymphoma; Hyperplasia Lymphoid Reactive

Keywords

miRNA; biomarker

Outcome Measures

Primary Outcomes (1)

• The concentration of miRNA expression quantitated in absolute copy numbers and their correlation in patients with reactive hyperplasia and lymphoma.

  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.

  Three years

Study Arms (2)

RLH

This group includes subjects diagnosed with reactive lymphoid hyperplasia.

Lymphoma

This group includes subjects diagnosed with lymphoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults 18 years and above
• Has condition related to lymphoma or reactive lymphoid hyperplasia

You may not qualify if:

• Age below 18 years
• Known pregnancy
• lymph tissue cannot be accessed

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead
• Chengdu Nuoen Biotechnologies, Inc.: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 610054, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Pseudolymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jian Huang, PhD

  University of Electronic Science and Technology of China

  STUDY DIRECTOR

Central Study Contacts

Juanjuan Kang

CONTACT

+ 86-28-83202351; kjj@immunet.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 30, 2017

Record last verified: 2016-08

Locations

CN (1)