Central China Rosai-Dorfman Disease Registry (CCR-DDR)

March 16, 2022 updated by: YIKAI YU, Tongji Hospital

A Trial to Evaluate the Long Term Prognosis in Rosai-Dorfman Disease

This is a research study among patients with Rosai-Dorfman disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rosai-Dorfman disease is a rare disorder characterized by overproduction (proliferation) and accumulation of a specific type of white blood cell (histiocyte) in the lymph nodes of the body (lymphadenopathy), most often those of the neck (cervical lymphadenopathy). In some cases, abnormal accumulation of histiocytes may occur in other areas of the body besides the lymph nodes (extranodal). These areas include the skin, central nervous system, kidney, and digestive tract. The symptoms and physical findings associated with Rosai-Dorfman disease vary depending upon the specific areas of the body that are affected. The disorder predominantly affects mainly adolescents or young adults. The exact cause of Rosa Dorfman disease is unknown. The purpose of this research study is to learn the prevalence , therapies and long term prognosis of Rosa Dorfman disease.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
          • AIHUA DU, M.D
          • Phone Number: +86 2783662886
        • Principal Investigator:
          • YIKAI YU, M.D
        • Sub-Investigator:
          • SHAOXIAN HU, M.D
        • Sub-Investigator:
          • WEI TU, M.D
        • Sub-Investigator:
          • RUI XING, M.D
        • Sub-Investigator:
          • CONG YE, M.D
        • Sub-Investigator:
          • FEI YU, M.D
        • Sub-Investigator:
          • GUIFEN SHEN, M.D
        • Sub-Investigator:
          • JIJUN YANG, M.D
        • Sub-Investigator:
          • MEI YU, M.D
        • Sub-Investigator:
          • XIAOFANG LUO, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings. All participants will undergo Standard of Care MRA, CTA or imaging examination.

Exclusion Criteria:

Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma) Prior stroke or intracranial hemorrhage Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease) Existing diagnosis of a psychiatric disorder or untreated mood disturbance Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease Chronic or daily excessive alcohol consumption as determined by the PI. History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past History of severe claustrophobia or other contraindications to patient SOC brain MRI Prior intravenous cytarabine or cladribine Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mycophenolate mofetil
Mycophenolate mofetil oral 500mg twice a day from baseline to week 108
Drug: Mycophenolate mofetil combined with oral prednisone
Mycophenolate mofetil oral 500mg twice a day combined with standard of care of oral prednisone 5mg-15mg/day from baseline to week 108

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autoimmune bullous disease quality of life (ABQoL)
Time Frame: From baseline to 108 Weeks
Total ABQoL scores range from 0 to 30 . The ABQoL score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
From baseline to 108 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Oral Corticosteroid Dose
Time Frame: From 12th, 24th, 36th ,52th and 108 Weeks
Calculate the Cumulative Oral Corticosteroid Dose
From 12th, 24th, 36th ,52th and 108 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: AIHUA DU, M.D, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tongji0509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Langerhans Cell Histiocytosis

Clinical Trials on Mycophenolate mofetil combined with oral prednisone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe