PREcision Medicine in Cancer in Odense, Denmark

Metastatic Solid Tumor Clinical Trial

— PRECODE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385081
• Other study ID #: PRECODE_S-20180147G
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Odense University Hospital
• Contact: Karin H Hansen
• Phone: 0045 29173453
• Email: karin.holmskov[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Solid Tumor

Intervention

Other:
• genomic profiling
next generation sequencing

Locations

Country	Name	City	State
Denmark	Odense Universitets Hospital dept of oncology	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Turn around time genomic profiling	Time from date of biopsi to date of available genomic profile discussed at tumor board meeting	through study completion, an average of 2 year
Secondary	Frequenc of matched treatment offer	Number of patients offered a treatment based on the genomic profile	through study completion, an average of 2 year