NCT04312854

Brief Summary

This is a cohort study to investigate the disease course and treatment response of patients with idiopathic retroperitoneal fibrosis（IRPF）. Methods: All the patients fulfilling diagnostic criteria of IRPF would be enrolled around China. A online database system will been established. Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IRPF patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2020Jan 2030

First Submitted

Initial submission to the registry

January 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

10 years

First QC Date

January 17, 2020

Last Update Submit

March 16, 2020

Conditions

Idiopathic Retroperitoneal Fibrosis

Keywords

idiopathic retroperitoneal fibrosisRegistrycohort study

Outcome Measures

Primary Outcomes (1)

  • Organ involvements of Chinese IRPF patients

    To calculate the percentage of organ involvements in at least 500 patients.

    5 years

Secondary Outcomes (5)

  • Response rate of glucocorticoids and immunosuppressants on IRPF in China

    5 years

  • Relapse rate of IRPF patients in China

    5 years

  • The correlation between baseline disease activities and relapse rate.

    5 years

  • Ten-year survival rate of patients with IRPF in China.

    10 years

  • The imaging features of involved organs.

    3 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with newly diagnosed IRPF

You may qualify if:

  • Males and females; 18-75 years old with informed consent; Patients diagnosed with definite or possible IRPF.

You may not qualify if:

  • Secondary forms of IRPF; Pregnant or Females planning to bear a child recently ; Concurrent severe and/or uncontrolled and/or unstable diseases; Patients with malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples(serum and plasma,with DNA)

MeSH Terms

Conditions

Retroperitoneal Fibrosis

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wen Zhang, MD

    Department of Rheumatology,Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Fei, MD

CONTACT

86-10-69158797feiyunyun2013@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2020

First Posted

March 18, 2020

Study Start

January 17, 2020

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)