NCT06204198

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 3, 2024

Last Update Submit

January 11, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Clinicopathological features checklist

    Clinicopathological features

    From September 2023 to September 2024

  • Postoperative survival of patients

    Prognosis

    From September 2023 to September 2024

  • Scores of patients' quality of life after surgery

    Patients' quality of life after surgery

    From September 2023 to September 2024

Interventions

No intervention

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Surgical retained or paraffin specimens were obtained from patients.

Study Officials

  • Yulong Shi, MD

    Shandong Provincial Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

September 1, 2023

Primary Completion

February 1, 2024

Study Completion

September 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations