Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer

Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer - COSMOS-VOLTAGE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040151

Enrollment

Registered

2020-04-14

Start date

2020-06-01

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

Resectable Locally Advanced Rectal Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with resectable LARC who will participate in VOLTAGE cohort D 2. Agree to receive preoperative chemoradiation 3. Age of >= 20 to < 80 years at time of informed consent 4. Willing to provide blood samples per protocol. 5. Has given written consent

Exclusion criteria

Exclusion criteria: 1. Pregnant. 2. Judged by the study doctor to be ineligible for the study for any other reason.

Design outcomes

Primary

Measure	Time frame
Positive rate of LUNAR assay	—

Secondary

Measure	Time frame
Correlation between post-operative positive rate of LUNAR assay and prognosis Correlation between status of LUNAR assay and efficacies of VOLTAGE treatment Concordance of gene status between LUNAR assay and tumor tissue Concordance of MSI status between LUNAR assay and tumor tissue Correlation between microbiome and the efficacies of the VOLTAGE study	—

Countries

Japan

Contacts

Public ContactHideaki Bando

Aichi Cancer Center Department of Clinical Oncology

hbando@aichi-cc.jp052-764-6111

Outcome results