A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial)

A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial) - A biomarker study to analyze ctDNA/CTC in gastrointestinal cancers (Valor trial)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036681

Enrollment

Registered

2019-05-08

Start date

2019-05-08

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

Gastrointestinal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically confirmed diagnosis of GI cancers (esophageal, gastric, pancreatic, colorectal cancers) (2) Patients who receive systemic chemotherapy in first- or second-lines / Patients with RAS wild-type mCRC treated with anti-EGFR antibody at any-lines (3) ECOG PS 0 or 1 (4) Patients agree with blood draw at several times for ctDNA and CTC analyses

Exclusion criteria

Exclusion criteria: (1) Patients who are regarded as inadequate for study enrollment by investigators. (2) Patients do not agree with use of samples

Design outcomes

Primary

Measure	Time frame
Concordance in genomic profiling between ctDNA and CTC	—

Secondary

Measure	Time frame
1. Association between genetic status in ctDNA and clinical outcomes 2. Association between genetic status in CTC and clinical outcome 3. Compare genetic change between ctDNA and CTC in mCRC patients with RAS wild-type tumors treated with anti-EGFR mAb.	—

Countries

Japan

Contacts

Public ContactShinko Hanaki

St. Marianna University School of Medicine Department of Clinical Oncology

rinshoushuyougaku-004@marianna-u.ac.jp044-977-8111

Outcome results