PREcision Medicine in Cancer in Odense, Denmark

NCT05385081 | Unknown DMC

• 1 other identifier: PRECODE_S-20180147G
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequenc of matched treatment offer

  through study completion, an average of 2 year

Study Arms (1)

genomic profiling

OTHER

After informed consent a PET/CT scan is performed to determine disease spread and the best location for core needle biopsi. Genomic profiling is performed using Next Generation Sequencing, NGS, genpanel analysis by Oncomine Comprehensive vs 3 The result of NGS is discussed at weekly local and national tumor board meeting to decide a possible targeted treatment offer based on genomic profiling or a possibly treatment offer in a clinical trial. Timelines in the course of investigation will be calculated using date of informed consent, PET/CT scan, biopsy, tumor board and date of start of next treatment, progression and death. If the genomic profiling results in a targeted treatment offer the Growth Modulation Index is calculated from progressions-free survival on recent and current treatment. Treatment given without an actionable target is likewise evaluated for efficacy.

Other: genomic profiling

Interventions

genomic profiling OTHER

next generation sequencing

genomic profiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense Universitets Hospital dept of oncology

Odense C, 5000, Denmark

RECRUITING

Related Publications (1)

• Hansen KH, Lyng MB, Kodahl AR, Asmussen JT, Arshad A, Petersen H, Krogh L, Ehmsen S, Kristensen TK, Ditzel HJ. Genomic profiling and expanded use of targeted anticancer drugs in solid cancers with exhausted evidence-based treatment options (PRECODE): study protocol of a prospective, non-randomized, cohort study. BMC Med Genomics. 2024 Nov 21;17(1):274. doi: 10.1186/s12920-024-02033-z.

  PMID: 39574115 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Genetic Profile

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Background; Genetic Phenomena

Study Officials

• Karin H Hansen

  Departement of Oncology Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin H Hansen

CONTACT

0045 29173453; karin.holmskov@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: prospective, single-center cohorte study

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: May 23, 2022
• Study Start: March 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)