Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall

January 11, 2024 updated by: Teng Qiong, Shandong Provincial Hospital

Analysis of Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall and Construction of Recurrence Risk Model

Aggressive fibromatosis, also known as desmoid fibromatosis or desmoid tumor, is a fibrous tumor that occurs in the fascia, aponeurosis, or deep soft tissue and is formed by excessive proliferation of fibroblasts and myofibroblasts. At present, the disease is considered to be a borderline tumor. Due to the unclear boundary of the tumor, it often grows into the surrounding adjacent tissues, which is difficult to remove completely and easy to relapse. It has been reported that nuclear β-catenin expression and CTNNB1 gene mutation can be used for the differential diagnosis of aggressive fibromatosis from other spindle cell lesions. At present, there is a lack of multicenter retrospective clinical study of this disease, and there is no literature report on the postoperative quality of life of this kind of patients. This study intends to further explore the clinicopathological features, prognosis and molecular typing of abdominal wall aggressive fibroma by retrospective analysis of the case data of multiple hospitals, as well as sequencing analysis of the retained specimens and paraffin specimens from previous operations, to study the high risk factors for recurrence of the disease, and to further comprehensively analyze the impact of abdominal wall aggressive fibroma surgery on the quality of life of patients through follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The data of all patients with abdominal wall aggressive fibroma were collected through the medical record system of the hospital, and the molecular characteristics of the disease were analyzed by sequencing of the specimens retained by previous surgery or paraffin specimens. The quality of life of patients was investigated by telephone or wechat follow-up to analyze the impact of postoperative disease on the quality of life of patients. As a retrospective and observational study, the data of this study will be statistically summarized according to the following general principles. Categorical data will be summarized descriptively using statistics including frequency n and percentage %, with 95% confidence intervals for overall percentages when necessary, and compared by chi-square or Fisher's exact test. Continuous data will be statistically described as mean ± standard deviation or median (min, Max) and compared by Mann-Whitney (U) test or t-test. The Kaplan-Meier method was used to estimate the survival function for time-to-event data, and survival curves were drawn to estimate the median time and 95% confidence intervals. The differences between groups were compared with the use of the Log-rank test. Cox proportional hazards model was used for univariate and multivariate analysis to screen independent prognostic factors related to recurrence, and the 95% confidence interval (CI) was recorded. All statistical tests were performed with the use of a two-sided 0.05 level. Statistical analysis will be calculated using SPSS 25 statistical analysis software.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
        • Sub-Investigator:
          • Qiong Teng
        • Principal Investigator:
          • Yulong Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent resection at our hospital for aggressive fibroma in the abdominal wall.

Description

Inclusion Criteria:

  • ① Surgical treatment for "invasive fibroma of abdominal wall"; ② Complete clinical data; ③ Agree to participate in the project.

Exclusion Criteria:

  • ① can not cooperate with the project implementation; ② There is cognitive dysfunction; Refuse to participate in research projects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinicopathological features checklist
Time Frame: From September 2023 to September 2024
Clinicopathological features
From September 2023 to September 2024
Postoperative survival of patients
Time Frame: From September 2023 to September 2024
Prognosis
From September 2023 to September 2024
Scores of patients' quality of life after surgery
Time Frame: From September 2023 to September 2024
Patients' quality of life after surgery
From September 2023 to September 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Provincial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yulong Shi, MD, Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWYX:NO.2023-601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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