LymphomaNCT03167476
Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma
An observational study of Lymphoma and Hyperplasia Lymphoid Reactive, run by University of Electronic Science and Technology of China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Hyperplasia Lymphoid Reactive
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults 18 years and above
- Has condition related to lymphoma or reactive lymphoid hyperplasia
Who cannot join
- Age below 18 years
- Known pregnancy
- lymph tissue cannot be accessed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
Huang Jian, Ph.D, + 86-28-83202351, hj@uestc.edu.cn
About this study
The objectives are to:
- validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
- investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
- investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.
Read more
The objectives are to:
- validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
- investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
- 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.
- Conditions
- Lymphoma, Hyperplasia Lymphoid Reactive
- Keywords
- miRNA, biomarker
- Medical subject headings
- Lymphoma, Pseudolymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RLH | This group includes subjects diagnosed with reactive lymphoid hyperplasia. | |
| Lymphoma | This group includes subjects diagnosed with lymphoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Aug 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Nuoen Biotechnologies, Inc., Sichuan Cancer Hospital and Research Institute
- Responsible party
- Sponsor
- Investigators
- Jian Huang, PhD, Study director, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167476
- Sponsor's protocol ID
- Uestc502
- Status last verified
- Aug 2016
- First submitted
- 24 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT03167476
- Acronym / sponsor ID
- Uestc502
- Conditions
- Lymphoma, Hyperplasia Lymphoid Reactive
- Keywords
- miRNA, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- Chengdu Nuoen Biotechnologies, Inc., Sichuan Cancer Hospital and Research Institute
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives are to:
- validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
- investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
- 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:
- validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
- investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLH | – | –This group includes subjects diagnosed with reactive lymphoid hyperplasia. |
| Lymphoma | – | –This group includes subjects diagnosed with lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults 18 years and above
- Has condition related to lymphoma or reactive lymphoid hyperplasia
Key exclusion criteria (3 listed)
- Age below 18 years
- Known pregnancy
- lymph tissue cannot be accessed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Huang, PhD study director
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Hyperplasia Lymphoid Reactive, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juanjuan Kang (+ 86-28-83202351, kjj@immunet.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of miRNA expression quantitated in absolute copy numbers and their correlation in patients with reactive hyperplasia and lymphoma. (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.