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
4085 - A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-601 in Patients with Advanced Solid Tumors
Presenter: Anthony Tolcher
Session: Poster Display session 1
Resources:
Abstract
1054 - Safety, efficacy, and pharmacokinetic (PK) profile of cosibelimab, an anti‐PD‐L1 antibody, in patients (pts) with advanced cancers
Presenter: Philip Clingan
Session: Poster Display session 1
Resources:
Abstract
4264 - A Phase I study of tinostamustine in patients (pts) with advanced solid tumours
Presenter: Alain Mita
Session: Poster Display session 1
Resources:
Abstract
3811 - Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors
Presenter: Santiago Ponce Aix
Session: Poster Display session 1
Resources:
Abstract
1311 - A phase I study of varlitinib (VAR; ASLAN001) an oral pan-HER tyrosine kinase inhibitor (TKI) combined with mFOLFIRI chemotherapy in advanced solid tumors
Presenter: Aaron Tan
Session: Poster Display session 1
Resources:
Abstract
3482 - Phase I study of lapatinib and trametinib in patients with KRAS mutant colorectal, non-small cell lung and pancreatic cancer
Presenter: Sanne Huijberts
Session: Poster Display session 1
Resources:
Abstract
4749 - Pharmacokinetic (PK) and updated survival data from the Canadian Cancer Trials Group IND.226 study of durvalumab ± tremelimumab in combination with platinum-doublet chemotherapy
Presenter: Desiree Hao
Session: Poster Display session 1
Resources:
Abstract
4530 - A Phase 2a clinical trial combining ALRN-6924 and palbociclib for the treatment of patients with tumors harboring wild-type p53 and MDM2 amplification or MDM2/CDK4 co-amplification
Presenter: Funda Meric-Bernstam
Session: Poster Display session 1
Resources:
Abstract
4280 - Updated Efficacy and Safety of Entrectinib in Patients with NTRK Fusion-Positive Tumors: Integrated Analysis of STARTRK-2, STARTRK-1 and ALKA-372-001
Presenter: Christian Rolfo
Session: Poster Display session 1
Resources:
Abstract
6144 - An international randomized cross-over bio-equivalence study of oral paclitaxel + HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumors
Presenter: Christopher Jackson
Session: Poster Display session 1
Resources:
Abstract