Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology

Completed

• Conditions: Advanced Solid Tumors or Hematologic Malignancies

• Registration Number: NCT04389541
• Lead Sponsor: iOMEDICO AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-17
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

Inclusion Criteria

• Advanced solid tumors (i.e. locally advanced, inoperable and/or metastatic) or hematologic malignancies not eligible for standard therapy options (i.e. without further treatment options with drugs approved for the specific indication based on the judgement of the treating physician)
• Started or completed at the documenting study site a non-standard targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics
• Results on molecular diagnostics (e.g. tumor genomic or protein expression test) must be available; based on these results the therapy decision was taken
• Targeted therapy (given as monotherapy or as part of a therapy regimen) must be non-standard at time point of patient registration in the eCRF
• Age ≥ 18 years
• Signed and dated informed consent form (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)

Exclusion Criteria

• Non-standard targeted therapy was given within a clinical trial
• The targeted therapy was given in a line of treatment for which it is non-standard (e.g. treatment in first line instead of second line where it is approved); the targeted therapy is however in principle approved for the given entity
• The targeted therapy was non-standard because a certain prior treatment has not been applied (e.g. targeted therapy is only approved after platin-based treatment but has been given without prior platin-based treatment); the targeted therapy is however in principle approved for the given entity
• The targeted therapy was non-standard because a different or no chemotherapy back-bone has been applied (e.g. targeted therapy is approved in combination with cisplatin but has been given with oxaliplatin or without chemotherapy backbone); the targeted therapy is however in principle approved for the given entity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate	Maximum 5 years	Proportion of patients with CR or PR as best response

Secondary Outcome Measures

Name	Time	Method
Time to treatment failure	Maximum 5 years	Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death
PFS ratio	Maximum 5 years	PFS ratio of targeted non-standard therapy and preceding treatment line
Patient and Disease Characteristics	maximum 5 years	Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.
Best overall response	Maximum 5 years	Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
Duration of Response	Maximum 5 years	Time from documentation of tumor response to disease progression or death from any cause
Details on molecular diagnostics	Maximum 5 years	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
Clinical decision making	Maximum 5 years (once per targeted therapy)	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
Evaluation of selected treatment approach assessed via project specific survey	Maximum 5 years (once per completed targeted therapy)	Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit
Disease Control Rate	Maximum 5 years	Proportion of patients with CR, PR or SD as best response
Time to Response	Maximum 5 years	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
Progression-free survival	Maximum 5 years	Time from start of treatment until disease progression or death
Overall Survival	Maximum 5 years	Time from start of treatment until death of any cause

Trial Locations

Locations (94)

MVZ am Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Studienzentrum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Onkologische Schwerpunktpraxis; 🇩🇪 Heidelberg, Germany

Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda; 🇩🇪 Bad Liebenwerda, Germany

Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH; 🇩🇪 Bamberg, Germany

Onkologische Schwerpunktpraxis Bamberg; 🇩🇪 Bamberg, Germany

Klinikum Bayreuth; Klinik für Onkologie und Hämatologie; 🇩🇪 Bayreuth, Germany

Onkologisches Versorgungszentrum Friedrichshain; 🇩🇪 Berlin, Germany

Onkologische Schwerpunktpraxis Kurfürstendamm; 🇩🇪 Berlin, Germany

Gemeinschaftspraxis für Onkologie und Hämatologie; 🇩🇪 Berlin, Germany

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