Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Aggression

Fibromatosis, Aggressive

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Desmoid Tumor

No intervention

Qiong Teng

Ronghua Zhang, MD

Yulong Shi

Yulong Shi, MD

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.

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.

Surgical retained or paraffin specimens were obtained from patients.

Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall

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

Shandong Provincial Hospital

Resident physician

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Gastrointestinal Stromal Tumors

Neuroendocrine Tumors

Glioma

Carcinosarcoma

Mixed Tumor, Mullerian

Adenocarcinoma, Clear Cell

Carcinoma, Small Cell

Seminoma

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Sex Cord-Gonadal Stromal Tumors

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Nerve Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Germinoma

Sarcoma

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Neuroendocrine Tumor

Germ Cells Tumors

Adenocarcinoma of the Appendix

Malignant Mixed Mullerian Tumor

Ovarian Germ Cell Tumor

Testicular Seminoma

Nonseminomatous Germ Cell Tumor

Neuroepithelioma

Central Nervous System Germinoma

Soft Tissue Sarcoma

On-site surveillance by a hospital physician

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Oncological Follow-up

Laurence ROTSAERT

Fanny BEN OUNE

Guillaume BONNET

Mathieu BOONE, MD

François GERNIER

Nicolas PENEL, MD

PENEL Nicolas, MD, PhD

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

* Long-term compliance (5-year follow-up)
* Use of care
* Oncological events and their management
* Supportive care needs

The exploratory objectives are to :

* Evaluate the costs in terms of medical transportation
* Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
* Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
* Evaluate the reasons for recruitment failures

Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Medical transport includes light medical vehicles and ambulances

Salary mass mobilized from a hospital perspective in both arms

Patients will answer a satisfaction survey (French Version of the Princess Margaret Hospital Satisfaction With Doctor) at different points of the study depending on their pathology

Patient reported outcomes will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire at different points of the study depending on their pathology.

The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression:

A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms.

In each investigating site, a screening log will be completed to find out the reasons for recruitment failures

Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date

Rate of patients lost to follow-up or quitting the surveillance program

* number of physical consultations at the investigator site
* number of emergency room visits for oncological reasons
* number of extra-hospital consultations for oncological reasons

Occurence and type of oncological event : relapse/progression.

The management of oncological events will be evaluated according to three criteria :

* completion of an oncological surgery
* implementation of a treatment by radiotherapy
* implementation of a systemic therapy such as chemotherapy

Time from randomization to first oncological event (progression/relapse) or death from any cause.

Time from randomization to death from any cause

Support care needs include :

* algology consultation
* nutrition/diet consultation
* psycho-oncology consultation
* social worker consultation
* job retention consultation

Canceropôle Nord Ouest

Groupement Interrégional de Recherche Clinique et d'Innovation

Centre Oscar Lambret

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall	NCT06204198	Aggressive Fibr...	No intervention	18 Years -	Shandong Provincial Hospital
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring	NCT05500391	Stage I Testicu... Stage I Testicu... Gastrointestina... Ovarian Germ Ce... Adenocarcinoma,... Borderline Ovar... Sex Cord-Stroma... Mucinous Adenoc... Carcinoma, Smal... Carcinosarcoma,... Serous Tumor of... Glioma Neuroendocrine ... Aggressive Fibr...	Oncological Fol...	18 Years -	Centre Oscar Lambret
Clinicopathological Features and Molecular Typing of Invasive Fibroma of Abdominal Wall	NCT06204198	Aggressive Fibr...	No intervention	18 Years -	Shandong Provincial Hospital

Spots Global Cancer Trial Database for aggressive fibromatosis of abdominal wall (disorder)