Clinical trial · Observational
Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies.
POSITive: Prospective Observational Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Liver Metastases | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Metastases | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort A: primarily operable disease, candidate to adjuvant | Genetic | — | UNRESOLVED |
| Cohort B: locally advanced disease | Genetic | — | UNRESOLVED |
| Cohort C: metastatic disease | Genetic | — | UNRESOLVED |
| Cohort D: Progressive disease | Genetic | — | UNRESOLVED |
| Cohort E: Hematological neoplasms | Genetic | — | UNRESOLVED |
| Cohort F: Toxicity | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Cohort A: primarily operable disease, candidate to adjuvant
- description
- This cohort includes any patient with nonmetastatic disease, candidate to surgery as primary treatment, for whom adjuvant therapy with targeted or immune therapy is recommended based on prior information obtained on the diagnostic biopsy. This cohort represents a control group, for whom high-throughput DNA/RNA sequencing is considered feasible in the vast majority of cases, and will not be considered in the computation of the primary endpoint. Small groups representative of relevant diseases will be collected, as follows: * Breast * Lung * Melanoma * Head and Neck * Urothelial * Colorectal cancer * Metastasectomy from lung or liver, from any cancer
- interventionNames
- Genetic: Cohort A: primarily operable disease, candidate to adjuvant
- label
- Cohort B: locally advanced disease
- description
- Patients in this cohort are eligible if diagnosed with or highly suspected of locally advanced (nonmetastatic) neoplasm and candidate to a diagnostic/confirmatory biopsy and subsequent treatment with targeted therapy, immune therapy or radiotherapy, where the treatment is administered with potentially curative intent. Patients in this cohort may be considered for enrolment prior to a formal diagnosis, so the study should be offered on the basis of a high suspicion of invasive cancer upon radiological evidence.Cohort B1: patients who, at the moment of biopsy, are expected to be subsequently treated with targeted therapy. Cohort B2: patients who, at the moment of biopsy, are expected to be subsequently treated with immune therapy. Cohort B3: patients who, at the moment of biopsy, are expected to be treated with combined chemo-immuno-radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available