Aggressive Fibromatosis of Abdominal Wall (Disorder)NCT06204198
Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall
An observational study of Aggressive Fibromatosis of Abdominal Wall (Disorder), run by Shandong Provincial Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive Fibromatosis of Abdominal Wall (Disorder)
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2024
- 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: Patients who underwent resection at our hospital for aggressive fibroma in the abdominal wall.
Who may be able to join
- ① Surgical treatment for "invasive fibroma of abdominal wall"; ② Complete clinical data; ③ Agree to participate in the project.
Who cannot join
- ① can not cooperate with the project implementation; ② There is cognitive dysfunction; Refuse to participate in research projects.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
Ronghua Zhang, MD, +8618800187833, zhangrh91@126.com
Qiong Teng
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicopathological features checklist
Clinicopathological features
Measured: From September 2023 to September 2024
Postoperative survival of patients
Prognosis
Measured: From September 2023 to September 2024
Scores of patients' quality of life after surgery
Patients' quality of life after surgery
Measured: From September 2023 to September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Sep 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive Fibromatosis of Abdominal Wall (Disorder)Studies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Teng Qiong, Shandong Provincial Hospital
- Investigators
- Yulong Shi, MD, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204198
- Sponsor's protocol ID
- SWYX:NO.2023-601
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall and Construction of Recurrence Risk Model
- ClinicalTrials.gov ID
- NCT06204198
- Acronym / sponsor ID
- SWYX:NO.2023-601
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent resection at our hospital for aggressive fibroma in the abdominal wall.
Key inclusion criteria (1 listed)
- ① Surgical treatment for "invasive fibroma of abdominal wall"; ② Complete clinical data; ③ Agree to participate in the project.
Key exclusion criteria (1 listed)
- ① can not cooperate with the project implementation; ② There is cognitive dysfunction; Refuse to participate in research projects.
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Clinicopathological features checklist
Time frame: From September 2023 to September 2024
Clinicopathological features
Postoperative survival of patients
Time frame: From September 2023 to September 2024
Prognosis
Scores of patients' quality of life after surgery
Time frame: From September 2023 to September 2024
Patients' quality of life after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Related trials for Aggressive Fibromatosis of Abdominal Wall (Disorder)
RecruitingPhase 2
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
Stage I Testicular Seminoma, Stage I Testicular Nonseminomatous Germ Cell Tumor
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.
Yulong Shi, MD study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aggressive Fibromatosis of Abdominal Wall (Disorder), run by Shandong Provincial Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiong Teng (18755138389, tengqiong2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicopathological features checklist (time frame: From September 2023 to September 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.