NCT05701150

Brief Summary

National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (\>30 genes)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

January 18, 2023

Last Update Submit

February 13, 2025

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (8)

  • Molecular tumorboard utilization

    Proportion of patients who's case was discussed in a Molecular tumorboard

    3 years

  • Treatment reality after NGS analysis

    Proportion of patients who received at least one targeted therapy based on NGS results, who exclusively received therapies other than targeted therapies based on NGS results or who did not receive any therapy

    3 years

  • NGS

    Genomic alterations identified by multi-gene NGS panels

    3 years

  • Molecular tumorboard

    Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation

    3 years

  • Overall response rate

    Overall response rate of targeted therapy based on NGS results

    3 years

  • Progression-free survival (PFS)

    Progression-free survival from start of targeted therapy based on NGS results

    3 years

  • Overall survival

    Overall survival from start of targeted therapy based on NGS results

    3 years

  • PFS ratio

    PFS interval associated with targeted therapy(ies) administered after NGS analysis divided by the time to progression (TTP) interval associated with the last prior treatment(s)

    3 years

Study Arms (2)

MIN Data Set

Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial)

Other: Minimal documentationOther: Extended documentation

EXT Data Set

Patients who received a targeted therapy based on NGS results (outside of a clinical trial)

Other: Extended documentation

Interventions

Minimal documentationOTHER

Minimal data documentation only of patients without targeted therapy based on NGS results

MIN Data Set
Extended documentationOTHER

Extended data documentation of patients with targeted therapy based on NGS results

EXT Data SetMIN Data Set

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) ineligible for curative treatment and with results available from multi-gene next-generation sequencing (NGS) panels (\>30 genes)

You may qualify if:

  • Diagnosis of advanced (i.e., locally advanced, inoperable, or metastatic) solid tumor, ineligible for curative surgery and/or curative systemic therapy
  • Available results of commercial or non-commercial RNA- and/or DNA-based multi-gene NGS panels with \>30 genes analyzed; for non-commercial panels a list of all tested genes and multiple gene biomarkers (e.g., tumor mutational burden (TMB), microsatellite status) must be provided
  • Age ≥ 18 years

You may not qualify if:

  • Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

RECRUITING

Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

NOT YET RECRUITING

Klinikum der Universität München

München, Bavaria, 81377, Germany

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue samples collected in clinical routine

Central Study Contacts

Marc Fischer

CONTACT

+49 30-8145344marc.fischer@aio-studien-ggmbh.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

December 8, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations

DE(3)