National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)
ALTITUDES
2 other identifiers
interventional
628
1 country
39
Brief Summary
The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
39 active sites
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
March 22, 2016
CompletedFirst Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
March 30, 2026
March 1, 2026
14.6 years
July 15, 2016
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Number of Aggressive Fibromatosis associated with familial adenomatous polyposis
through study completion, an average of 5 years
Percentage of CTNNB1 mutation in non-selected cases of Aggressive Fibromatosis
through study completion, an average of 5 years
Management of AF
through study completion, an average of 5 years
Hospital Anxiety and Depression Scale (HADS)
at baseline, one year
Quality of Life Questionnaire (QLQC30)
at baseline, one year
- +3 more secondary outcomes
Other Outcomes (8)
Mutation rate of APC
through study completion, an average of 5 years
Mutation rate of CTNNB1
through study completion, an average of 5 years
Correlation between APC and CTNNB1 mutations rates
through study completion, an average of 5 years
- +5 more other outcomes
Study Arms (1)
Study procedure
OTHERTumor biobank realization (biopsy...) and biobank constitution. coloscopy associated with colonic chromoscopy. Blood sampling (facultative). Pain evaluation
Interventions
Constitution of a biobank with pre-therapeutic or post-therapeutic biopsy or resected tissues
For adult patients, a coloscopy with chromoscopy of ascending and sigmoid colon will be performed
Blood sample can be collected at diagnostic or after medically significant events (progressive disease, local or systemic treatment, pregnancy...)
Realization of a tumor biobank is part of classical procedure of participating centers
Pain evaluation (EVA scale), anxiety (HADS questionnaire), quality of life questionnaire (EORTC-QLQ-C30)
Eligibility Criteria
You may qualify if:
- 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 β-Catenin Gene, CTNNB1)
- Affiliation to the National Health System
- Informed consent signed (both parents signature for non adult patients)
You may not qualify if:
- Administrative or legal measure of liberty privation
- Patient not able to give consent or unwilling to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovationcollaborator
- Centre Oscar Lambretlead
- Ligue contre le cancer, Francecollaborator
- Institut Curiecollaborator
- Hôpital de la Timonecollaborator
- SOS Desmoid e.V.collaborator
- APICIL fundingcollaborator
- GIRCI NOcollaborator
- UNICANCERcollaborator
Study Sites (39)
Institut de Cancérologie de l'Ouest - Paul Papin
Angers, 49055, France
CHU Angers
Angers, 49933, France
CHU de Besançon
Besançon, 25030, France
Hôpital des Enfants
Bordeaux, 33076, France
Institut Bergonié
Bordeaux, 33076, France
CHU de Caen-Côte de Nacre
Caen, 14033, France
Centre François Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc
Dijon, 21079, France
CHU de Grenoble- Hôpital Couple Enfant
Grenoble, 38043, France
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital la Timone Enfants Service Oncologie Pédiatrique
Marseille, 13005, France
Hôpital la Timone Service Oncologie Médicale
Marseille, 13005, France
Institut Paoli Calmettes
Marseille, 13273, France
ICM Val d'Aurelle
Montpellier, 34298, France
Hôpital Mère Enfant - CHU Nantes
Nantes, 44093, France
Hôpital Archet 2
Nice, 06202, France
Institut Curie Département Oncologie Médicale
Paris, 75005, France
Institut Curie Département Oncologie Pédiatrique
Paris, 75005, France
Hôpital Saint Louis
Paris, 75010, France
Hôpîtal d'Enfants Armand Trousseau
Paris, 75012, France
Hôpital Cochin
Paris, 75014, France
Hôpital Saint Antoine
Paris, France
CHU de Reims
Reims, 51100, France
CHU de Rennes- Hôpital Sud
Rennes, 35023, France
Centre Henri Becquerel
Rouen, 76038, France
Institut Curie-Hôpital René Huguenin
Saint-Cloud, 92210, France
CHU Saint-Étienne - Hôpital Nord
Saint-Etienne, 42055, France
Hôpital Privé de la Loire
Saint-Etienne, 42100, France
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, 44805, France
Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
Saint-Priest-en-Jarez, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098, France
CHU Toulouse - Hôpital des Enfants
Toulouse, 31059, France
Institut Claudius Régaud
Toulouse, 31059, France
CHU Tours - Clocheville
Tours, 37044, France
Hôpital d'Enfants- CHU Nancy
Vandœuvre-lès-Nancy, 54511, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94800, France
Related Publications (1)
Penel N, Bonvalot S, Bimbai AM, Meurgey A, Le Loarer F, Salas S, Piperno-Neumann S, Chevreau C, Boudou-Rouquette P, Dubray-Longeras P, Kurtz JE, Guillemet C, Bompas E, Italiano A, Le Cesne A, Orbach D, Thery J, Le Deley MC, Blay JY, Mir O. Lack of Prognostic Value of CTNNB1 Mutation Profile in Desmoid-Type Fibromatosis. Clin Cancer Res. 2022 Sep 15;28(18):4105-4111. doi: 10.1158/1078-0432.CCR-21-4235.
PMID: 35294527DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas PENEL, PhD
Centre Oscar Lambret
- PRINCIPAL INVESTIGATOR
Sébastien SALAS, PhD
Hopital Timone adultes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2016
First Posted
August 15, 2016
Study Start
March 22, 2016
Primary Completion (Estimated)
November 1, 2030
Study Completion (Estimated)
November 1, 2030
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share