An observational study in Advanced Solid Tumors or Hematologic Malignancies, sponsored by iOMEDICO AG. Completed at 97 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by iOMEDICO AG · Observational
The retrospective cohort study INFINITY will be an instrument to analyze the current practice of precision oncology in the real-world setting. It will provide insight into real-world biomarker-directed treatment of cancer patients not eligible for standard therapies. The study will retrospectively collect medical records' data of patients who received a targeted treatment based on a potentially actionable alteration or biomarker identified by molecular diagnostics. Data of deceased patients will be included. The study will analyze how molecular test results guided clinical decision making. The compiled treatment and outcome data will be a valuable resource to analyze the use and effectiveness of targeted therapy approaches in biomarker-defined and entity-defined subpopulations of cancer patients. These signals might generate new insights and foster progress of targeted cancer treatment. The associated biomarker profiling module aims to set up a decentral biobank for future research on molecular alterations or central re-testing.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 499 is above the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →iOMEDICO AG is the lead sponsor of 52 studies on the registry; 14 are open to participants now.
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Adult patients with advanced solid tumors or hematologic malignancies not eligible for standard therapies who received a targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics
Exclusion Criteria:
Overall response rate
Proportion of patients with CR or PR as best response
Time frame: Maximum 5 years
Patient and Disease Characteristics
Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.
Time frame: maximum 5 years
Details on molecular diagnostics
Frequency of type of molecular diagnostic testing performed, of single gene/protein tests, multigene panels or NGS in molecular diagnostics, of type (by panel size) of NGS library sequenced, of proteins and genes tested, of altered proteins and genes, if tested, of treatment recommendations given in molecular diagnostic reports, of implemented treatment recommendations given in molecular diagnostic reports, of the use of a molecular tumor board (MTB), of implementation of the treatment recommendation given by MTB and duration from molecular testing result to start of non-standard targeted treatment
Time frame: Maximum 5 years
Clinical decision making
Frequency of answers rated with a Likert scale on patient's non-suitability for standard therapy options / choice of performed molecular diagnostics / choice of selected molecular target and targeted non-standard therapy / reasons for the selection of targeted non-standard therapy / primary goal of the non-standard targeted therapy / expected advantages of the non-standard targeted therapy and frequency of ESMO Scale of Clinical Actionability for molecular Targets (ESCAT) evidence levels
Time frame: Maximum 5 years (once per targeted therapy)
Evaluation of selected treatment approach assessed via project specific survey
Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit
Time frame: Maximum 5 years (once per completed targeted therapy)
Best overall response
Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
Time frame: Maximum 5 years
Disease Control Rate
Proportion of patients with CR, PR or SD as best response
Time frame: Maximum 5 years
Time to Response
Time from start of treatment to the first objective tumor response (e.g., tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR
Time frame: Maximum 5 years
Duration of Response
Time from documentation of tumor response to disease progression or death from any cause
Time frame: Maximum 5 years
Time to treatment failure
Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death
Time frame: Maximum 5 years
Progression-free survival
Time from start of treatment until disease progression or death
Time frame: Maximum 5 years
PFS ratio
PFS ratio of targeted non-standard therapy and preceding treatment line
Time frame: Maximum 5 years
Overall Survival
Time from start of treatment until death of any cause
Time frame: Maximum 5 years
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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iOMEDICO AG