NCT07010224

Brief Summary

This study aims to retrospectively evaluate patients who underwent surgical treatment for elastofibroma dorsi, a rare benign tumor typically located in the subscapular region of the chest wall. The study will analyze demographic and clinical features, risk factors, diagnostic imaging methods, postoperative complications, and recurrence rates. By identifying potential predictors of complications and recurrence, the study hopes to contribute to the understanding and management of this silent and often incidental lesion.

Trial Health

53
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
active not recruiting

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

Study Start

First participant enrolled

January 1, 2010

Completed
15.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 12, 2025

Status Verified

May 1, 2025

Enrollment Period

15.8 years

First QC Date

May 30, 2025

Last Update Submit

September 7, 2025

Conditions

Keywords

Elastofibroma DorsiSubscapular MassChest Wall TumorRisk FactorsThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Completion of Retrospective Data Collection Form

    Completion of data collection from medical records of patients diagnosed with elastofibroma dorsi who underwent surgical treatment, including demographic features, clinical presentation, imaging modalities, surgical outcomes, postoperative complications, and recurrence.

    Within 3 months after data collection begins

Study Arms (1)

Surgically Treated Elastofibroma Dorsi Patients

This cohort includes patients diagnosed with elastofibroma dorsi who underwent surgical resection between 2010 and 2025. Patients were retrospectively evaluated for demographic characteristics, clinical features, diagnostic methods, surgical findings, postoperative complications, and recurrence during follow-up.

Other: Retrospective Medical Record Review

Interventions

Review of archived medical, surgical, and radiological records of patients diagnosed with elastofibroma dorsi and treated surgically. No active intervention was administered as part of the study.

Surgically Treated Elastofibroma Dorsi Patients

Eligibility Criteria

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

The study population consists of adult patients (aged 18 and older) who were diagnosed with elastofibroma dorsi and underwent surgical resection at a single tertiary care center between 2010 and 2025. All included patients had histopathologically confirmed diagnoses and at least one month of postoperative follow-up available in hospital records.

You may qualify if:

  • Patients who underwent surgical treatment for elastofibroma dorsi
  • Histopathological confirmation of the diagnosis
  • Minimum of 1-month postoperative follow-up available
  • Age 18 years or older
  • Accessible medical and imaging records in hospital archives
  • Signed informed consent available in patient records (if applicable)

You may not qualify if:

  • Patients diagnosed with elastofibroma dorsi but not treated surgically
  • Cases without histopathological confirmation
  • Incomplete or insufficient medical and radiological records
  • Postoperative follow-up period less than 1 month
  • Patients younger than 18 years
  • Absence of documented informed consent (if applicable)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nishio J, Isayama T, Iwasaki H, Naito M. Elastofibroma dorsi: diagnostic and therapeutic algorithm. J Shoulder Elbow Surg. 2012 Jan;21(1):77-81. doi: 10.1016/j.jse.2011.01.043. Epub 2011 Apr 27.

    PMID: 21524925BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Caner İşevi, Thoracic Surgeon, Department of Thoracic Surgery, Ondokuz Mayıs University

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

January 1, 2010

Primary Completion

September 30, 2025

Study Completion

December 1, 2025

Last Updated

September 12, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share