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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167476
• Other study ID #: Uestc502
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2017
• Last updated: May 24, 2017
• Start date: August 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2016
• Source: University of Electronic Science and Technology of China
• Contact: Juanjuan Kang
• Phone: + 86-28-83202351
• Email: kjj[@]immunet.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Hyperplasia Lymphoid Reactive
• Lymphoma

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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