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Aggressive FibromatosisALTITUDESNCT02867033

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

A study testing biopsy, biobank constitution and Coloscopy in people with Aggressive Fibromatosis, run by Centre Oscar Lambret at 39 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Any age
Conditions the study is for
Aggressive Fibromatosis
What is being tested?
biopsy, biobank constitution and Coloscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
628 participants
Where
39 sitesFrance
Study dates
22 Mar 2016to Nov 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Administrative or legal measure of liberty privation
  • Patient not able to give consent or unwilling to provide consent

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

France39 sites

  • Institut de Cancérologie de l'Ouest - Paul Papin

    Angers, 49055

  • CHU Angers

    Angers, 49933

  • CHU de Besançon

    Besançon, 25030

  • Hôpital des Enfants

    Bordeaux, 33076

  • Institut Bergonié

    Bordeaux, 33076

  • CHU de Caen-Côte de Nacre

    Caen, 14033

  • Centre François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21079

  • CHU de Grenoble- Hôpital Couple Enfant

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital la Timone Enfants Service Oncologie Pédiatrique

    Marseille, 13005

  • Hôpital la Timone Service Oncologie Médicale

    Marseille, 13005

  • Institut Paoli Calmettes

    Marseille, 13273

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Hôpital Mère Enfant - CHU Nantes

    Nantes, 44093

  • Hôpital Archet 2

    Nice, 06202

  • Institut Curie Département Oncologie Médicale

    Paris, 75005

  • Institut Curie Département Oncologie Pédiatrique

    Paris, 75005

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpîtal d'Enfants Armand Trousseau

    Paris, 75012

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Saint Antoine

    Paris

  • CHU de Reims

    Reims, 51100

  • CHU de Rennes- Hôpital Sud

    Rennes, 35023

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Curie-Hôpital René Huguenin

    Saint-Cloud, 92210

  • CHU Saint-Étienne - Hôpital Nord

    Saint-Etienne, 42055

  • Hôpital Privé de la Loire

    Saint-Etienne, 42100

  • Institut de Cancérologie de l'Ouest - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne

    Saint-Priest-en-Jarez

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67098

  • CHU Toulouse - Hôpital des Enfants

    Toulouse, 31059

  • Institut Claudius Régaud

    Toulouse, 31059

  • CHU Tours - Clocheville

    Tours, 37044

  • Hôpital d'Enfants- CHU Nancy

    Vandœuvre-lès-Nancy, 54511

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis

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

Read the detailed 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.

Being tested
biopsy, biobank constitution, Coloscopy, Blood sampling (facultative), Pain evaluation
Keywords
desmoid tumour
Medical subject headings
Desmoid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biopsyProcedure or surgery

    pre-therapeutic or post-therapeutic biopsy or resected tissues

  • biobank constitutionOther

    Constitution of a biobank with pre-therapeutic or post-therapeutic biopsy or resected tissues

  • ColoscopyProcedure or surgery

    For adult patients, a coloscopy with chromoscopy of ascending and sigmoid colon will be performed

  • Blood sampling (facultative)Procedure or surgery

    Blood sample can be collected at diagnostic or after medically significant events (progressive disease, local or systemic treatment, pregnancy...)

  • Pain evaluationOther

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

  • Tumor biobank realizationProcedure or surgery

    Realization of a tumor biobank is part of classical procedure of participating centers

Study groups in NCT02867033
Study groupRoleWhat they receive
Study procedureOtherTumor biobank realization (biopsy...) and biobank constitution. coloscopy associated with colonic chromoscopy. Blood sampling (facultative). Pain evaluation
Receives: Procedure: biopsy; Other: biobank constitution; Procedure: Coloscopy; Procedure: Blood sampling (facultative); Other: Pain evaluation; Procedure: Tumor biobank realization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: through study completion, an average of 5 years

Secondary outcomes (8)

  1. Number of Aggressive Fibromatosis associated with familial adenomatous polyposis

    To describe and analyse the link between Aggressive Fibromatosis and familial adenomatous polyposis

    Measured: through study completion, an average of 5 years

  2. Percentage of CTNNB1 mutation in non-selected cases of Aggressive Fibromatosis

    To describe the proportion of AF cases characterized by CTNNB1 somatic mutation

    Measured: through study completion, an average of 5 years

  3. 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.

    Measured: through study completion, an average of 5 years

  4. 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.

    Measured: at baseline, one year

  5. 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.

    Measured: at baseline, one year

  6. 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

    Measured: Through study completion, an average of 5 years

  7. Incidence of polyposis and colorectal cancer

    Rate of polyposis and colorectal cancer in the AF population

    Measured: Through study completion, an average of 5 years

  8. Pain

    Pain according to Numeric Pain Scale, assessed at baseline and then at each annual follow-up.

    Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start22 Mar 2016
  3. Primary completionNov 2030 (estimated)
  4. Study completionNov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867033
Sponsor's protocol ID
ALTITUDES-1508
Other IDs
2015-A01655-44
Acronym
ALTITUDES
Status last verified
Mar 2026
First submitted
15 Jul 2016
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Penel N, Bonvalot S, Elices-Diez J, Italiano A, Verret B, Kurtz JE, Dubray-Longeras P, Guillemet C, Duffaud F, Bertucci F, Thery J, Vanseymortier M, Bompas E, Firmin N, De Percin S, Wallet J, Piperno-Neumann S, Valentin T, Blay JY, Le Deley MC. Head & Neck and Shoulder Desmoid-Type Fibromatosis: Presentation and Natural History of These Ultra-Rare Locations. Cancer Med. 2026 Oct;15(10):e72302. doi: 10.1002/cam4.72302.

    PubMed 42905937

  • 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.

    PubMed 35294527

Questions about this trial

What is this clinical trial studying?

A study testing biopsy, biobank constitution and Coloscopy in people with Aggressive Fibromatosis, run by Centre Oscar Lambret at 39 sites in France.

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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident cases of aggressive fibromatosis, diagnosed after 01/01/2016 in France (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867033, which also lists 2 linked publications.

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 30 Mar 2026.

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