Abstract 1666
Background
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 is most frequently (about 85%) sporadic and then associated with a somatic mutation of the CTNNB1 gene. In about 15% of cases, AF is associated with heredity condition, as complication of familial adenomatous polyposis FAP (with germinal mutation of APC gene). The natural course of AF is unpredictable. As the consequence the decision making for starting curative intent treatment is difficult. Therapeutic options are: wait-and-see policy, surgery (sometimes mutilating), radiotherapy or systemic treatment (non-steroidal anti-inflammatory drugs, hormonal therapy, chemotherapy, sorafenib). Regarding these uncertainties, physicians can hardly answer to patient questions.
Trial design
ALTITUDES is a national multicenter cohort of 600 patients who will be included in 39 centers (NCT02867033). The primary outcome is number of cases diagnosed in reference centers. Secondary outcomes are rate of cases related to FAP, rate of cases associated with CTNNB1 mutations, description of natural history, description of management, impact in terms of Anxiety and Depression, in QoL. Main eligibility criteria are a diagnosis later than 01/01/2016, with central pathological review. A translational part is attached to this cohort. On the one hand, the purpose is detection of FA specific CTNNB1 mutations using a targeted strategy Digital-droplet PCR (ddPCR) on cell-free DNA (cfDNA) extracted from blood samples and to correlate total plasmatic cfDNA concentration with natural history. On the other hand, We hypothesize that APC and CTNNB1 mutations are mutually exclusive and that patients with a CTNNB1 mutation do not have an increased risk of developing polyposis and/or colon cancer and therefore should not benefit from screening colonoscopy. In this study, colonoscopy is mandatory and a search for somatic mutations of CTNNB1 and APC. Since opening of enrolment (03/2016), 360 patients were included. Along these patients, 316 were included in the translational part. End of recruitment is planned 03/2022.
Clinical trial identification
NCT02867033.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Institut Curie.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5054 - Inhibition of Rspo-Wnt pathway Facilitates Checkpoint Blockade Therapy by anti-RSPO3 antibody (DBPR117)
Presenter: John Hsu
Session: Poster Display session 1
Resources:
Abstract
3305 - A phase I dose-escalation and expansion trial of intratumorally administered CV8102, alone and in combination with anti-PD-1 in patients with advanced solid tumors
Presenter: Jürgen Krauss
Session: Poster Display session 1
Resources:
Abstract
5353 - Phase 1/2 Study of 9-ING-41, a small molecule selective Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematological Malignancies or Solid Tumors
Presenter: Benedito Carneiro
Session: Poster Display session 1
Resources:
Abstract
3946 - Trial in progress: a Phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors (NCT03447314).
Presenter: Aaron Hansen
Session: Poster Display session 1
Resources:
Abstract
3449 - Radiographic Phenotyping to Identify Intracranial Disseminated Recurrence in Brain metastases Treated With Radiosurgery Using Contrast-enhanced MR Imaging
Presenter: CheYu Hsu
Session: Poster Display session 1
Resources:
Abstract
4553 - Association between TP53 mutations and efficacy of Osimertinib for brain metastasis from EGFR-mutant lung cancer
Presenter: Lijuan Chen
Session: Poster Display session 1
Resources:
Abstract
4942 - Response assessment of melanoma brain metastases treated by stereotactic radiotherapy or immunotherapy or both: a comparison of RECIST 1.1, RANO and iRANO criteria
Presenter: Emilie Le Rhun
Session: Poster Display session 1
Resources:
Abstract
3529 - Management of multiple brain metastases by Staged SRS focusing on utmost risk lesions
Presenter: shaoqun Li
Session: Poster Display session 1
Resources:
Abstract
5315 - Whole brain radiotherapy plus simultaneous in-field boost versus whole brain radiotherapy plus fractionated stereotactic radiotherapy for multiple brain metastases of non-small cell lung cancer
Presenter: Lu Li
Session: Poster Display session 1
Resources:
Abstract
1116 - 3D based texture analysis serving as potential diagnostic factor in discriminating primary central nervous system lymphoma from metastatic brain tumors: A preliminary study
Presenter: Wen Guo
Session: Poster Display session 1
Resources:
Abstract