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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Centre Oscar Lambret
Sponsor:
Collaborators:
Ligue contre le cancer, France
Institut Curie
Hôpital de la Timone
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT02867033
First received: July 15, 2016
Last updated: August 16, 2016
Last verified: August 2016
July 15, 2016
August 16, 2016
March 2016
June 2021   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02867033 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • Quality of life questionnaires [ Time Frame: at baseline, one year ]
    To describe the impact of AF management/efficacy on psychological, emotional and social parameters, and quality of life. And to compare changes between the time of diagnosis and one year after the treatments used.
  • 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
  • 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
  • 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
  • APC mutation rate [ Time Frame: through study completion, an average of 5 years ]
    To correlate mutational somatic and constitutional rate of APC gene
  • 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)
  • 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
  • AF outcome [ Time Frame: through study completion, an average of 5 years ]
    To describe patient outcomes and identify prognostic factors
  • Treatment response [ Time Frame: through study completion, an average of 5 years ]
    To search for factors involved in response treatment prediction
Same as current
 
National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Aggressive Fibromatosis
  • 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
Study procedure
Tumor biobank realization (biopsy...) and biobank constitution. coloscopy associated with colonic chromoscopy. Blood sampling (facultative). Pain evaluation
Interventions:
  • Procedure: biopsy
  • Other: biobank constitution
  • Procedure: Coloscopy
  • Procedure: Blood sampling (facultative)
  • Other: Pain evaluation
  • Procedure: Tumor biobank realization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2021
June 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
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
France
 
 
NCT02867033
ALTITUDES-1508
No
Not Provided
Plan to Share IPD: No
Centre Oscar Lambret
Centre Oscar Lambret
  • Ligue contre le cancer, France
  • Institut Curie
  • Hôpital de la Timone
Principal Investigator: Penel Nicolas, MD Centre Oscar Lambret
Principal Investigator: Salas Sébastien, MD Hopital Timone adultes
Centre Oscar Lambret
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP