Clinical trial · Interventional
SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
(ImmunotheRapy SyMptom CApture) A RANDOMIZED CONTROLLED TRIAL OF SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
- 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)
Immune-related adverse events (irAEs) can be different in their onset, kinetics and presentation but unlike chemotherapy are seldom predictable. Toxicity can affect nearly any organ system and multiple presentations of rare but severe irAEs have been reported, highlighting the relevance of vigilant monitoring. Although early detection and timely management of high grade or special interest irAEs (such as cardiac and neurological) is obvious, it is unclear whether early identification of less serious events can lead to clinical benefit. Furthermore, it is of the utmost importance to develop new tools which can increase identification of side effects. The current study investigates systematic symptom assessment through an electronic patient reported outcome tool and aims to define whether this can reduce the rate of serious irAEs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systematic symptom assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- ARM A
- description
- Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0)
- interventionNames
- Other: Systematic symptom assessment
- type
- OTHER
- label
- Arm B
- description
- Standard symptom reporting following the conventional modalities of clinical oncology practice
- interventionNames
- Other: Systematic symptom assessment
Primary outcomes (1)
- measure
- 1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old at time of signing Informed Consent Form * Histologically documented diagnosis of locally advanced or metastatic lung cancer (NSCLC or SCLC), surgically resected or advanced melanoma * Patients eligible for immunotherapy in any line of treatment, either alone or in combination with other immunotherapy drugs or with chemotherapy * Signed Informed Consent Form * Life expectancy ≥3 months * ECOG Performance Status of ≤2 * Adequate hematologic and end-organ function, defined by laboratory test result by investigator's judgment * Viral hepatitis screening: 1. Negative hepatitis B surface antigen (HBsAg) test 2. For patients with positive total HBcAb test, hepatitis B virus (HBV) DNA test is required 3. For patients with positive HCV antibody test, hepatitis C virus (HCV) RNA test is required Exclusion Criteria: * Patients receiving immunotherapy at time of enrollment * \> 1 grade adverse events from previous treatments * Any uncontrolled symptom * Clinically unstable brain metastases (i.e., symptomatic, not treated with RT and rapidly evolving)
References
Publications (0)
Data not yet available