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

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ClinicalTrials.gov Identifier: NCT02867033
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
Ligue contre le cancer, France
Institut Curie
Hôpital de la Timone
Information provided by (Responsible Party):
Centre Oscar Lambret

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

Condition or disease Intervention/treatment Phase
Aggressive Fibromatosis Procedure: biopsy Other: biobank constitution Procedure: Coloscopy Procedure: Blood sampling (facultative) Other: Pain evaluation Procedure: Tumor biobank realization Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis
Study Start Date : March 2016
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study procedure
Tumor biobank realization (biopsy...) and biobank constitution. coloscopy associated with colonic chromoscopy. Blood sampling (facultative). Pain evaluation
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

Procedure: 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




Primary Outcome Measures :
  1. Incident cases of aggressive fibromatosis [ Time Frame: through study completion, an average of 5 years ]
    To constitute, at a national level, the largest cohort of incident cases of desmoid tumours


Secondary Outcome Measures :
  1. Number of Aggressive Fibromatosis associated with familial adenomatous polyposis [ Time Frame: through study completion, an average of 5 years ]
    To describe and analyse the link between Aggressive Fibromatosis and familial adenomatous polyposis

  2. Percentage of CTNNB1 mutation in non-selected cases of Aggressive Fibromatosis [ Time Frame: through study completion, an average of 5 years ]
    To describe the proportion of AF cases characterized by CTNNB1 somatic mutation

  3. Treatment used for management of AF [ Time Frame: through study completion, an average of 5 years ]
    To describe the impact of different therapeutic strategies on AF recurrence and progression free survival, in homogenous risk level sub-groups of patients

  4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: at baseline, one year ]
    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.

  5. Quality of Life Questionnaire (QLQC30) [ Time Frame: at baseline, one year ]
    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.


Other Outcome Measures:
  1. Mutation rate of APC [ Time Frame: through study completion, an average of 5 years ]
    To determine the mutation rate of APC at constitutional and somatic levels

  2. Mutation rate of CTNNB1 [ Time Frame: through study completion, an average of 5 years ]
    To determine the mutation rate of CTNNB1 at constitutional and somatic levels

  3. Correlation between APC and CTNNB1 mutations rates [ Time Frame: through study completion, an average of 5 years ]
    To demonstrate that APC and CTNNB1 mutations are two mutually exclusive molecular alterations

  4. APC mutation rate [ Time Frame: through study completion, an average of 5 years ]
    To correlate mutational somatic and constitutional rate of APC gene

  5. Occurrence of other mutations [ Time Frame: through study completion, an average of 5 years ]
    To search other molecular anomalies for patients without APC or CTNNB1 mutations (10 % of cases)

  6. Cell free (circulating) nucleic acid extraction technics [ Time Frame: through study completion, an average of 5 years ]
    To determine sensibility and specificity of cell free (circulating) nucleic acid extraction techniques

  7. AF outcome [ Time Frame: through study completion, an average of 5 years ]
    To describe patient outcomes and identify prognostic factors

  8. Treatment response [ Time Frame: through study completion, an average of 5 years ]
    To search for factors involved in response treatment prediction



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Incident Case of aggressive fibromatosis in France
  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867033


Contacts
Contact: Decoupigny Emilie +33 (0) 3 20 29 59 18 promotion@o-lambret.fr
Contact: Penel Nicolas, MD +33 (0) 3 20 29 59 18 n-penel@o-lambret.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Angers, France
Principal Investigator: PROUST Stéphanie, MD         
Institut de Cancérologie de l'Ouest - Paul Papin Recruiting
Angers, France
Principal Investigator: BOMPAS Emmanuelle, MD         
CHU de Besançon Recruiting
Besancon, France
Contact       lchaigneau@chu-besancon.fr   
Principal Investigator: CHAIGNEAU Loïc, MD         
Hôpital des enfants Recruiting
Bordeaux, France
Contact       cecile.verite@chu-bordeaux.fr   
Principal Investigator: VERITE Cécile, MD         
Institut Bergonié Recruiting
Bordeaux, France
Principal Investigator: ITALIANO Antoine, MD         
Centre François Baclesse Recruiting
Caen, France
Principal Investigator: DELCAMBRE Corinne, MD         
CHU de Caen-Côte de Nacre Recruiting
Caen, France
Contact       minckes-o@chu-caen.fr   
Principal Investigator: MINCKES Odile, MD         
Centre Jean Perrin Recruiting
Clermont Ferrand, France
Contact       jobay@chu-clermontferrand.fr   
Principal Investigator: BAY Jacques Olivier, PhD         
Centre Georges François Leclerc Recruiting
Dijon, France
Principal Investigator: ISAMBERT Nicolas, MD         
CHU de Grenoble- Hôpital Couple Enfant Recruiting
Grenoble, France
Contact       DPlantaz@chu-grenoble.fr   
Principal Investigator: PLANTAZ Dominique, PhD         
Centre Oscar Lambret Recruiting
Lille, France
Principal Investigator: PENEL Nicolas, MD         
Sub-Investigator: DEFACHELLES Anne-Sophie, MD         
Sub-Investigator: LERVAT Cyril, MD         
Centre Léon Bérard Recruiting
Lyon, France
Contact       nadege.corradini@lyon.unicancer.fr   
Principal Investigator: CORRADINI Nadège, MD         
Hôpital la Timone Enfants Service Oncologie Pédiatrique Recruiting
Marseille, France
Principal Investigator: ROME Angélique, MD         
Hôpital la Timone Service Oncologie Médicale Recruiting
Marseille, France
Principal Investigator: DUFFAUD Florence, PhD         
Institut Paoli Calmettes Recruiting
Marseille, France
Contact       bertuccif@ipc.unicancer.fr   
Principal Investigator: BERTUCCI François, PhD         
ICM Val d'Aurelle Recruiting
Montpellier, France
Contact       didier.cupissol@icm.unicancer.fr   
Principal Investigator: CUPISSOL Didier, MD         
Hôpital Mère Enfant - CHU Nantes Not yet recruiting
Nantes, France
Contact       sophie.dumoucel@chu-nantes.fr   
Principal Investigator: RIGAUD Charlotte, MD         
Centre Antoine Lacassagne Withdrawn
Nice, France
Hôpital Archet 2 Recruiting
Nice, France
Contact       soler.c@chu-nice.fr   
Principal Investigator: SOLER Christine, MD         
Hôpital Cochin Recruiting
Paris, France
Contact       pascaline.boudou@aphp.fr   
Principal Investigator: BOUDOU- ROUQUETTE Pascaline, MD         
Hôpital Saint Antoine Recruiting
Paris, France
Contact       thierry.andre@aphp.fr   
Principal Investigator: ANDRE Thierry, PhD         
Hôpital Saint Louis Recruiting
Paris, France
Principal Investigator: LEBBE Céleste, PhD         
Hôpîtal Armand-Trousseau Recruiting
Paris, France
Principal Investigator: PETIT A, Pr         
Institut Curie Département Oncologie Médicale Recruiting
Paris, France
Contact       sophie.piperno-neumann@curie.fr   
Principal Investigator: PIPERNO-NEUMANN Sophie, MD         
Institut Curie Département Oncologie Pédiatrique Recruiting
Paris, France
Contact       daniel.orbach@curie.fr   
Principal Investigator: ORBACH Daniel, MD         
Centre Hospitalier Universitaire Not yet recruiting
Reims, France
Principal Investigator: PHUCHART C, MD         
CHU de Rennes- Hôpital Sud Recruiting
Rennes, France
Contact       alexis.arnaud@chu-rennes.fr   
Principal Investigator: ARNAUD Alexis, MD         
Centre Henri Becquerel Recruiting
Rouen, France
Contact: GUILLEMET Cécile, MD       cecile.guillemet@chb.unicancer.fr   
Principal Investigator: GUILLEMET Cécile, MD         
Institut Curie-Hôpital René Huguenin Recruiting
Saint Cloud, France
Contact       laurence.bozec@curie.fr   
Principal Investigator: BOZEC Laurence, MD         
Institut de Cancérologie de l'Ouest - Site René Gauducheau Recruiting
Saint Herblain, France
Principal Investigator: BOMPAS Emmanuelle, MD         
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint Priest En Jarez, France
Contact       olivier.collard@icloire.fr   
Principal Investigator: COLLARD Olivier, MD         
Centre Hospitalier Universitaire Recruiting
Saint-Étienne, France
Principal Investigator: BERGER Claire, MD         
Centre Hospitalier Régional Universitaire Recruiting
Strasbourg, France
Principal Investigator: KURTZ JE, Pr         
CHU Toulouse - Hôpital des Enfants Recruiting
Toulouse, France
Contact       castex.mp@chu-toulouse.fr   
Principal Investigator: CASTEX Marie-Pierre, MD         
Institut Claudius Régaud Recruiting
Toulouse, France
Principal Investigator: CHEVREAU Christine, MD         
CHU Tours - Clocheville Not yet recruiting
Tours, France
Contact       p.blouin@chu-tours.fr   
Principal Investigator: BLOUIN Pascale, MD         
Hôpital d'Enfants- CHU Nancy Recruiting
Vandoeuvre Les Nancy, France
Contact       p.chastagner@chu-nancy.fr   
Principal Investigator: CHASTAGNER Pascal, PhD         
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre Les Nancy, France
Principal Investigator: RIOS Maria, MD         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: MIR Olivier, MD       olivier.mir@gustaveroussy.fr   
Principal Investigator: MIR Olivier, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Ligue contre le cancer, France
Institut Curie
Hôpital de la Timone
Investigators
Principal Investigator: Penel Nicolas, MD Centre Oscar Lambret
Principal Investigator: Salas Sébastien, MD Hopital Timone adultes

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02867033     History of Changes
Other Study ID Numbers: ALTITUDES-1508
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
desmoid tumour

Additional relevant MeSH terms:
Aggression
Fibroma
Fibromatosis, Aggressive
Behavioral Symptoms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms