Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer

Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer - Investigation of ctDNA gene alterations associated with treatment resistance in RAS wild-type metastatic colorectal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059801

Enrollment

790

Registered

2025-11-18

Start date

2025-11-05

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who participated in the main study of the PARADIGM trial and provided consent for ancillary studies. 2) Patients enrolled in the PARADIGM trial between May 2015 and June 2017. 3) Patients whose study information has been disclosed through an opt-out process and who have not declined participation.

Exclusion criteria

Exclusion criteria: Patients who were excluded from data analysis in the PARADIGM trial

Design outcomes

Primary

Measure	Time frame
Comparison of genomic alterations between tumor tissue and ctDNA before treatment initiation Changes in ctDNA genomic alterations before and after treatment Impact of treatment regimen and treament duration on changes in ctDNA genomic alterations Association between ctDNA genomic alterations and patient survival before and after treatment Characterization of clinical features in cases harboring multiple genomic alterations	—

Measure

Time frame

Comparison of genomic alterations between tumor tissue and ctDNA before treatment initiation Changes in ctDNA genomic alterations before and after treatment Impact of treatment regimen and treament duration on changes in ctDNA genomic alterations Association between ctDNA genomic alterations and patient survival before and after treatment Characterization of clinical features in cases harboring multiple genomic alterations

—

Countries

Japan

Contacts

Public ContactSara Horie

National Cancer Center Research Institute Division of Molecular Oncology

sahorie@ncc.go.jp03-3542-2511

Outcome results