NCT03886155

Brief Summary

The investigators will prospectively evaluate for the presence of amyloid deposits in soft tissue samples obtained from patients undergoing trigger finger release surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

March 20, 2019

Last Update Submit

December 21, 2021

Conditions

AmyloidosisTrigger FingerTransthyretin AmyloidosisPrimary Amyloidosis of Light Chain Type

Keywords

SurgerySurgical releaseBiopsy

Outcome Measures

Primary Outcomes (1)

  • Incidence of amyloidosis in older patients undergoing trigger finger release

    Incidence of amyloid deposits in soft tissue removed from trigger finger tenosynovium in older patients undergoing trigger finger release surgery

    Baseline to 30 days

Study Arms (1)

Trigger Finger Biopsy

Biopsy of trigger finger tenosynovial tissue during trigger finger release surgery sent to pathology for amyloid-specific analysis

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

During clinically-scheduled trigger finger release surgery, soft tissue will be removed from the trigger finger tenosynovium (which may include synovial sheath and subcutaneous fat tissue) and send to pathology to be analyzed with amyloid-specific staining.

Trigger Finger Biopsy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing trigger finger release surgery

You may qualify if:

  • Age ≥50 years at the time of surgical biopsy.
  • Undergoing surgical intervention for idiopathic trigger finger.
  • Able to consent.

You may not qualify if:

  • Known history of amyloidosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

  • Cordiner-Lawrie S, Diaz J, Burge P, Athanasou NA. Localized amyloid deposition in trigger finger. J Hand Surg Br. 2001 Aug;26(4):380-3. doi: 10.1054/jhsb.2001.0571.

    PMID: 11469845BACKGROUND

  • Sperry BW, Reyes BA, Ikram A, Donnelly JP, Phelan D, Jaber WA, Shapiro D, Evans PJ, Maschke S, Kilpatrick SE, Tan CD, Rodriguez ER, Monteiro C, Tang WHW, Kelly JW, Seitz WH Jr, Hanna M. Tenosynovial and Cardiac Amyloidosis in Patients Undergoing Carpal Tunnel Release. J Am Coll Cardiol. 2018 Oct 23;72(17):2040-2050. doi: 10.1016/j.jacc.2018.07.092.

    PMID: 30336828BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Trigger finger tenosynovium (may contain tenosynovial tissue and subcutaneous fat)

MeSH Terms

Conditions

AmyloidosisTrigger Finger DisorderAmyloidosis, Hereditary, Transthyretin-RelatedImmunoglobulin Light-chain Amyloidosis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesTendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mazen A Hanna, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

May 1, 2019

Primary Completion

July 2, 2020

Study Completion

December 2, 2021

Last Updated

December 22, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)