NCT04092244

Brief Summary

to detect the role of CTHRC1 biomarker in diagnosis of rheumatoid arthritis and To correlate other well-established rheumatoid arthritis markers (RF\& anti-ccp) and CTHRC1 level to see if CTHRC1 can act as a dependent or independent serum marker in prediction of RA status.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

September 15, 2019

Last Update Submit

May 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • detect value of CTHRC1 in diagnosis of rheumatoid arthritis

    detect the role of CTHRC1 biomarker in diagnosis of rheumatoid arthritis and To compare the sensitivity and the specificity of CTHRC1 in relation to other biomarkers used in diagnosis of RA.

    baseline

Interventions

CTHRC1 biomarkerDIAGNOSTIC_TEST

its a biomarker detected in the serum of the patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include the following: * 35 RA patients with negative anti\_ccp. * 35 RA patients with negative RF. * 45 RA patients either positive RF or anti-ccp. * 30 other Arthritic patients. * 25 healthy controls.

You may qualify if:

  • All RA patients must fulfill the 2010 ACR/EULAR criteria for RA.
  • Healthy individual must be without a prior history of chronic inflammation or any form of arthritis.

You may not qualify if:

  • \- Patients with solid tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, Kavanaugh A, McInnes IB, Solomon DH, Strand V, Yamamoto K. Rheumatoid arthritis. Nat Rev Dis Primers. 2018 Feb 8;4:18001. doi: 10.1038/nrdp.2018.1.

    PMID: 29417936BACKGROUND
  • Shekhani MT, Forde TS, Adilbayeva A, Ramez M, Myngbay A, Bexeitov Y, Lindner V, Adarichev VA. Collagen triple helix repeat containing 1 is a new promigratory marker of arthritic pannus. Arthritis Res Ther. 2016 Jul 19;18:171. doi: 10.1186/s13075-016-1067-1.

    PMID: 27430622BACKGROUND
  • Song YW, Kang EH. Autoantibodies in rheumatoid arthritis: rheumatoid factors and anticitrullinated protein antibodies. QJM. 2010 Mar;103(3):139-46. doi: 10.1093/qjmed/hcp165. Epub 2009 Nov 19.

    PMID: 19926660BACKGROUND
  • Singal DP, Li J, Zhu Y. Genetic basis for rheumatoid arthritis. Arch Immunol Ther Exp (Warsz). 1999;47(5):307-11.

    PMID: 10604236BACKGROUND
  • Nell VP, Machold KP, Stamm TA, Eberl G, Heinzl H, Uffmann M, Smolen JS, Steiner G. Autoantibody profiling as early diagnostic and prognostic tool for rheumatoid arthritis. Ann Rheum Dis. 2005 Dec;64(12):1731-6. doi: 10.1136/ard.2005.035691. Epub 2005 May 5.

    PMID: 15878904BACKGROUND
  • Lefevre S, Knedla A, Tennie C, Kampmann A, Wunrau C, Dinser R, Korb A, Schnaker EM, Tarner IH, Robbins PD, Evans CH, Sturz H, Steinmeyer J, Gay S, Scholmerich J, Pap T, Muller-Ladner U, Neumann E. Synovial fibroblasts spread rheumatoid arthritis to unaffected joints. Nat Med. 2009 Dec;15(12):1414-20. doi: 10.1038/nm.2050. Epub 2009 Nov 8.

    PMID: 19898488BACKGROUND
  • Han B, Pouget JG, Slowikowski K, Stahl E, Lee CH, Diogo D, Hu X, Park YR, Kim E, Gregersen PK, Dahlqvist SR, Worthington J, Martin J, Eyre S, Klareskog L, Huizinga T, Chen WM, Onengut-Gumuscu S, Rich SS; Major Depressive Disorder Working Group of the Psychiatric Genomics Consortium; Wray NR, Raychaudhuri S. A method to decipher pleiotropy by detecting underlying heterogeneity driven by hidden subgroups applied to autoimmune and neuropsychiatric diseases. Nat Genet. 2016 Jul;48(7):803-10. doi: 10.1038/ng.3572. Epub 2016 May 16.

    PMID: 27182969BACKGROUND
  • Durmus T, LeClair RJ, Park KS, Terzic A, Yoon JK, Lindner V. Expression analysis of the novel gene collagen triple helix repeat containing-1 (Cthrc1). Gene Expr Patterns. 2006 Oct;6(8):935-40. doi: 10.1016/j.modgep.2006.03.008. Epub 2006 Mar 17.

    PMID: 16678498BACKGROUND
  • Ding B, Padyukov L, Lundstrom E, Seielstad M, Plenge RM, Oksenberg JR, Gregersen PK, Alfredsson L, Klareskog L. Different patterns of associations with anti-citrullinated protein antibody-positive and anti-citrullinated protein antibody-negative rheumatoid arthritis in the extended major histocompatibility complex region. Arthritis Rheum. 2009 Jan;60(1):30-8. doi: 10.1002/art.24135.

    PMID: 19116921BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 17, 2019

Study Start

August 1, 2020

Primary Completion

November 28, 2021

Study Completion

December 30, 2021

Last Updated

May 28, 2020

Record last verified: 2020-05