Elastofibroma DorsiNCT07010224
Elastofibroma Dorsi: Clinical Features, Surgical Outcomes, and Risk Factors
An observational study of Elastofibroma Dorsi, run by Ondokuz Mayıs University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elastofibroma Dorsi
- What is being tested?
- Retrospective Medical Record Review
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
Official title: Clinical Characteristics of Elastofibroma Dorsi, Long-Term Outcomes After Surgical Resection, and Analysis of Risk Factors
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.
- Conditions
- Elastofibroma Dorsi
- Being tested
- Retrospective Medical Record Review
- Keywords
- Elastofibroma Dorsi, Subscapular Mass, Chest Wall Tumor, Risk Factors, Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Medical Record ReviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Retrospective Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months after data collection begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jan 2010
- Primary completion30 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elastofibroma DorsiStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010224
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/280
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 21524925Isevi C, Celik B, Pirzirenli MG, Omur F, Elverdi HF, Buyukkarabacak Y. Elastofibroma dorsi: determinants of symptom burden, bilaterality, and perioperative morbidity in 102 surgically treated patients. BMC Surg. 2026 Apr 27;26(1):405. doi: 10.1186/s12893-026-03770-x.
PubMed 42045899
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Elastofibroma Dorsi, Long-Term Outcomes After Surgical Resection, and Analysis of Risk Factors
- ClinicalTrials.gov ID
- NCT07010224
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/280
- Conditions
- Elastofibroma Dorsi
- Keywords
- Elastofibroma Dorsi, Subscapular Mass, Chest Wall Tumor, Risk Factors, Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgically Treated Elastofibroma Dorsi Patients | – | Other: Retrospective Medical Record ReviewThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Medical Record ReviewReview 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. | Other | Surgically Treated Elastofibroma Dorsi Patients |
Primary outcome
Completion of Retrospective Data Collection Form
Time frame: Within 3 months after data collection begins
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Results publication: PubMed 21524925Nishio 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.
- Derived from this study: PubMed 42045899Isevi C, Celik B, Pirzirenli MG, Omur F, Elverdi HF, Buyukkarabacak Y. Elastofibroma dorsi: determinants of symptom burden, bilaterality, and perioperative morbidity in 102 surgically treated patients. BMC Surg. 2026 Apr 27;26(1):405. doi: 10.1186/s12893-026-03770-x.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Elastofibroma Dorsi, run by Ondokuz Mayıs University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Retrospective Data Collection Form (time frame: Within 3 months after data collection begins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07010224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.