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PREcision Medicine in Cancer in Odense, Denmark

PREcision Medicine in Cancer in Odense, Denmark (PRECODE) Feasibility of Genomic Profiling and Frequency of Genomic Matched Treatment in Solid Tumors With no Treatment Options

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05385081
Acronym
PRECODE
Enrollment
900
Registered
2022-05-23
Start date
2019-03-01
Completion date
2023-12-31
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Solid Tumor

Brief summary

The traditional approach to cancer treatment has changes from using drugs approved for the specific cancer diagnosis to a tumor agnostic approach when treating solid tumors. How often will tumor biopsy and genomic profiling in patients with advanced solid tumors with no further evidence based treatment options result in biomarker-driven targeted treatment ? Feasibility of the investigation of patients and median turnaround time from biopsy to available genomic profile is evaluated.

Detailed description

Genomic profiling in patients with advanced solid tumors and no further evidence based treatment options is a newer approach. The frequency of genomic alterations varies between individual tumor types and the actionability of somatic variants are different but evolves in line with the development of new targeted drugs. In accordance with expected short survival short assessment time is important to minimize the risk of patient detoriation during the investigation. A fresh biopsy from lesions in progression is preferred for analysis. To minimize the duration of the genomic profiling a genpanel analysis covering the most frequent oncogene targets is preferred. The primary objective is to evaluate the feasibility of the investigational procedures. The secondary objective is to investigate how often genomic changes in tumor tissue gives rise to a targeted treatment offer and to evaluate the clinical benefit using the Growth Modulation Index.

Interventions

next generation sequencing

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

prospective, single-center cohorte study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Written informed consent * Age ≥ 18 years * Diagnosis of advanced solid tumors * Evidence based treatment options are exhausted * Performance Status 0-2 * Adequate organ function * Life expectancy of at least 3 months

Exclusion criteria

• inclusions criteria not met

Design outcomes

Primary

MeasureTime frameDescription
Turn around time genomic profilingthrough study completion, an average of 2 yearTime from date of biopsi to date of available genomic profile discussed at tumor board meeting

Secondary

MeasureTime frameDescription
Frequenc of matched treatment offerthrough study completion, an average of 2 yearNumber of patients offered a treatment based on the genomic profile

Countries

Denmark

Contacts

Primary ContactKarin H Hansen
karin.holmskov@rsyd.dk0045 29173453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026