Breast Cancer Clinical Trial
— POSITiveOfficial title:
POSITive: Prospective Observational Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies
NCT number | NCT06321640 |
Other study ID # | IEO 1777 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 8, 2022 |
Est. completion date | December 31, 2025 |
Novel treatment modalities like targeted therapies and Immune checkpoint inhibitors have revolutionised the therapeutic landscape in oncology and hematology, significantly improving outcomes even in clinical contexts in which little improvement had been observed for decades such as metastatic melanoma, lung cancer, and lymphoproliferative neoplasms such as chronic lymphoid leukemia or Hodgkin lymphoma. However, major issues remain unsolved, given the frequent occurrence of primary or secondary resistance and the still incomplete understanding of the physiopathology of adverse events, which represent a major cause of morbidity and treatment interruption and often remain difficult to treat and diagnose. In this complex landscape, identifying the best treatment option for each patient remains challenging. For both targeted therapies and Immune checkpoint inhibitors, several biomarkers have been reported, but their implementation in clinical practice is still uncommon, and most of the decision-making process remains based on purely clinical considerations or constraints dictated by the regulatory bodies. Obstacles to biomarker-driven decision making are manifold and include insufficient understanding of the underlying biology, lack of strong evidence on their predictive power and limited tumor sampling, which may be circumvented by non-invasive techniques such as liquid biopsies.
Status | Recruiting |
Enrollment | 265 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age>18 yrs old - histological diagnosis of any cancer - signed informed consent - fulfills criteria described in cohort definition - Clinical indication for a diagnostic biopsy Exclusion Criteria: Performance Status (ECOG) >2 - life expectancy < 3 months - unwilling to receive treatment at IEO for at least 6 months after enrolment - active pregnancy at the moment of enrolment - for cohort F: use of steroids (higher than 10 mg prednisone-equivalent) or other major immunosuppressive drug (e.g. tocilizumab) in the 14 days prior to the baseline sample collection. |
Country | Name | City | State |
---|---|---|---|
Italy | European Institute of oncology | Milan |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients in each cohort that will obtain a full "core" omic characterization. | For cohorts A-E:
i) Whole Exome Sequencing of tumor samples (biopsy/surgery) ii) ribonucleic acid sequence iii) Whole-genome "shotgun" metagenomic sequencing of fecal samples For cohorts C and D: i) Computation of the 11-parameter multivariable score: clonal Tumor Mutation Load, indel Tumor Mutation Load, nonsense mediated decay-escape Tumor Mutation Load, tobacco signature etc. For cohorts E,F i) High throughput cytokine bead array on plasma samples ii) ribonucleic acid sequence iii) Whole-genome "shotgun" metagenomic sequencing of fecal samples |
2 months | |
Secondary | Percentage of patients with complete clinical data collection over the expected follow-up time and with successful biobanking. | Percentage of patients with complete clinical and laboratory data collection over the expected follow-up time (2 years); Percentage of patients with successful biobanking (presence of at least 1 frozen tumor sample, 1 vial of EDTA blood, 2 vials of plasma at T0, T1, T2, 1 vial of feces at T0, T1, T2).Somatic mutations associated with sensitivity, primary/secondary resistance and toxicity;Prevalence of specific signaling-pathway transcriptional-activation signatures associated with sensitivity, primary/secondary resistance and toxicity;Prevalence of specific microbiota signatures associated with sensitivity, primary/secondary resistance and toxicity; Prevalence of germline variants associated with sensitivity, primary/secondary resistance and toxicity; | 2 years |
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