National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)

Aggressive Fibromatosis Clinical Trial

— ALTITUDES  

Official title:

National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02867033
• Other study ID #: ALTITUDES-1508
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2016
• Est. completion date: November 2031

Study information

• Verified date: May 2024
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.

Description:

Aggressive fibromatosis (AF) is a rare non-metastasizing connective tissue tumor (< 300 cases/year in France), associated with high risk of local relapse, functional impairment and pain. AF can occur at any age, but most commonly between 25 and 40 with a significant female predominance. AF is most frequently (about 85%) sporadic and then associated with a somatic mutation of the CTNNB1 gene. AF is associated with heredity condition, as complication of familial adenomatous polyposis (with germinal mutation of Adenomatous polyposis coli (APC) gene). Most of AF arises on lims or abdominal wall. Nevertheless, some particular locations are life-threatening (mesenteric or cervical locations). The natural course of AF is unpredictable. One third of tumors are spontaneously stable. One third of tumor spontaneously decreases. One third of tumor is progressive, with a non-linear tumor growth dynamic. As the consequence the decision making for starting curative intent treatment is difficult, since some treatment could be mutilating (large en bloc surgery) or associated with late and severe complications (radiotherapy) and since these treatments could fail to control this benign tumor. Therapeutic options are: wait-and-see policy, surgery (sometimes mutilating), radiotherapy or systemic treatment (non-steroidal anti-inflammatory drugs, hormonotherapy, imatinib, chemotherapy). Level of evidence associated these options is very low, based on retrospective studies and rare non-randomized phase II clinical trials.

Regarding these uncertainties, physicians can hardly answer to patient questions.

Prospective data provided by a large multi-center cohort is needed. The objective of the present study is to create a large cohort of incident cases of AF associated with tumor bank and collection of blood samples.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 628
• Est. completion date: November 2031
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Incident Case of aggressive fibromatosis in France, diagnosed after 01/01/2016

• Confirmed diagnosis by the French anatomopathological diagnosis network (including search for mutation of the ß-Catenin Gene, CTNNB1)

• Affiliation to the National Health System

• Informed consent signed (both parents signature for non adult patients)

Exclusion Criteria:

• Administrative or legal measure of liberty privation

• Patient not able to give consent or unwilling to provide consent

Related Conditions & MeSH terms

• Aggression
• Aggressive Fibromatosis
• Fibroma

Intervention

Procedure:
• biopsy
pre-therapeutic or post-therapeutic biopsy or resected tissues

Other:
• biobank constitution
Constitution of a biobank with pre-therapeutic or post-therapeutic biopsy or resected tissues

Procedure:
• Coloscopy
For adult patients, a coloscopy with chromoscopy of ascending and sigmoid colon will be performed
• Blood sampling (facultative)
Blood sample can be collected at diagnostic or after medically significant events (progressive disease, local or systemic treatment, pregnancy...)

Other:
• Pain evaluation
Pain evaluation (EVA scale), anxiety (HADS questionnaire), quality of life questionnaire (EORTC-QLQ-C30)

Procedure:
• Tumor biobank realization
Realization of a tumor biobank is part of classical procedure of participating centers

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Institut de Cancérologie de l'Ouest - Paul Papin	Angers
France	CHU de Besançon	Besancon
France	Hôpital des Enfants	Bordeaux
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen
France	CHU de Caen-Côte de Nacre	Caen
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Georges François Leclerc	Dijon
France	CHU de Grenoble- Hôpital Couple Enfant	Grenoble
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Hôpital la Timone Enfants Service Oncologie Pédiatrique	Marseille
France	Hôpital la Timone Service Oncologie Médicale	Marseille
France	Institut Paoli Calmettes	Marseille
France	ICM Val d'Aurelle	Montpellier
France	Hôpital Mère Enfant - CHU Nantes	Nantes
France	Hôpital Archet 2	Nice
France	Hôpital Cochin	Paris
France	Hôpîtal d'Enfants Armand Trousseau	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Saint Louis	Paris
France	Institut Curie Département Oncologie Médicale	Paris
France	Institut Curie Département Oncologie Pédiatrique	Paris
France	CHU de Reims	Reims
France	CHU de Rennes- Hôpital Sud	Rennes
France	Centre Henri Becquerel	Rouen
France	Institut Curie-Hôpital René Huguenin	Saint Cloud
France	Institut de Cancérologie de l'Ouest - Site René Gauducheau	Saint Herblain
France	Institut de Cancérologie Lucien Neuwirth	Saint Priest En Jarez
France	CHU Saint-Étienne - Hôpital Nord	Saint-Étienne
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	CHU Toulouse - Hôpital des Enfants	Toulouse
France	Institut Claudius Régaud	Toulouse
France	CHU Tours - Clocheville	Tours
France	Hôpital d'Enfants- CHU Nancy	Vandoeuvre Les Nancy
France	Institut de Cancérologie de Lorraine	Vandoeuvre Les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Hôpital de la Timone, Institut Curie, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mutation rate of APC	To determine the mutation rate of APC at constitutional and somatic levels	through study completion, an average of 5 years
Other	Mutation rate of CTNNB1	To determine the mutation rate of CTNNB1 at constitutional and somatic levels	through study completion, an average of 5 years
Other	Correlation between APC and CTNNB1 mutations rates	To demonstrate that APC and CTNNB1 mutations are two mutually exclusive molecular alterations	through study completion, an average of 5 years
Other	APC mutation rate	To correlate mutational somatic and constitutional rate of APC gene	through study completion, an average of 5 years
Other	Occurrence of other mutations	To search other molecular anomalies for patients without APC or CTNNB1 mutations (10 % of cases)	through study completion, an average of 5 years
Other	Cell free (circulating) nucleic acid extraction technics	To determine sensibility and specificity of cell free (circulating) nucleic acid extraction techniques	through study completion, an average of 5 years
Other	AF outcome	To describe patient outcomes and identify prognostic factors	through study completion, an average of 5 years
Other	Treatment response	To search for factors involved in response treatment prediction	through study completion, an average of 5 years
Primary	Incident cases of aggressive fibromatosis, diagnosed after 01/01/2016 in France	To constitute, at a national level, the largest cohort of incident cases of desmoid tumours	through study completion, an average of 5 years
Secondary	Number of Aggressive Fibromatosis associated with familial adenomatous polyposis	To describe and analyse the link between Aggressive Fibromatosis and familial adenomatous polyposis	through study completion, an average of 5 years
Secondary	Percentage of CTNNB1 mutation in non-selected cases of Aggressive Fibromatosis	To describe the proportion of AF cases characterized by CTNNB1 somatic mutation	through study completion, an average of 5 years
Secondary	Management of AF	Description of the management of AF. Study of prognosis factor for progressive disease and death. Study of tumor response to treatments (Best response and progression-free survival) according to RECIST 1.1.	through study completion, an average of 5 years
Secondary	Hospital Anxiety and Depression Scale (HADS)	To describe the psychological impact of the disease at diagnosis and a year after diagnosis. And to compare changes between the time of diagnosis and one year after the treatments used.	at baseline, one year
Secondary	Quality of Life Questionnaire (QLQC30)	To describe the consequences of the disease on the quality of life at diagnosis and a year after diagnosis. And to compare changes between the time of diagnosis and one year after the treatments used.	at baseline, one year
Secondary	Impact of pregnancy and hormonal exposure	To study the impact of pregnancy and hormonal exposure on the evolution of the disease according to recurrence/progression rates	Through study completion, an average of 5 years
Secondary	Incidence of polyposis and colorectal cancer	Rate of polyposis and colorectal cancer in the AF population	Through study completion, an average of 5 years