Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies.

RecruitingOBSERVATIONAL
Enrollment

265

Participants

Timeline

Start Date

July 8, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Breast CancerLung CancerMelanomaHead and Neck CancerUrothelial CarcinomaColorectal CancerLiver MetastasesLung Metastases
Interventions
GENETIC

Cohort A: primarily operable disease, candidate to adjuvant

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

GENETIC

Cohort B: locally advanced disease

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.

GENETIC

Cohort C: metastatic disease

In this cohort, patients are eligible if diagnosed with invasive cancer with radiologically proven metastatic localization and candidate to treatment with targeted or immune therapy.

GENETIC

Cohort D: Progressive disease

In this cohort, patients are eligible if a tumor biopsy is considered indicated by the referring physician upon disease progression to prior treatment in the metastatic setting or for hematological neoplasms. Definition of progression is based on the investigator's judgement and does not strictly require RECIST 1.1 definition, although all relevant radiological data will be collected whenever possible. Tumor biopsy must be collected no more than 6 months after the documented date of progression.

GENETIC

Cohort E: Hematological neoplasms

Any patient that is expected to be treated with targeted agents. Special consideration will be given to patients affected by chronic lymphoid leukemia and follicular lymphoma treated with BTKi, PI3Ki, BCL-2i +/- monoclonal antibodies. Any patient that is expected to be treated with immunotherapy. Special consideration will be given to patients affected by Hodgkin lymphoma and Diffuse Large B-cell lymphoma treated with ICIs, Tafasitamab/Lenalidomide, immunoconjugates.

GENETIC

Cohort F: Toxicity

In this cohort, patients are enrolled upon experiencing an adverse event of grade 3/4 as per CTCAE v 5.0 that, in the opinion of the investigator, is unequivocally caused by a targeted or immune therapeutic. The event may occur at any time after the last dose of the drug. Events may be of any nature but particular attention will be given to those events for which pathophysiology is currently poorly understood (severe myocardial or neurologic Immune-related events or DS-8201-induced pneumonitis)

Trial Locations (1)

Unknown

RECRUITING

European Institute of oncology, Milan

All Listed Sponsors
lead

European Institute of Oncology

OTHER