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Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with colorectal cancer and advanced adenoma

Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with colorectal cancer and advanced adenoma - COSMOS-CRC-01

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000037765
Enrollment
500
Registered
2019-09-01
Start date
2020-01-20
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 and advanced adenoma.

Interventions

None listed

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. >= 20 years of age at the time of enrollment. 2. Confirmed as either of the following a-f by colonoscopy within 60 days before the enrollment. a. Advanced colorectal adenoma (>= 10mm adenoma) b. Clinical stage 0 (TisN0M0 c. Clinical stage I (T1-2N0M0) d. Clinical stage IIA (T3N0M0) e. Clinical stage IIB (T4aN0M0) f. Clinical stage IIC (T4bN0M0) 3. Planned a resection for the colorectal cancer or advanced adenoma in the eligibility criteria #2. 4. Willing to provide blood samples per protocol. 5. Has given written consent.

Exclusion criteria

Exclusion criteria: 1. Have previous history of cancer, including colorectal cancer, within 10 years before the enrollment. 2. Have previous history of colorectal advanced adenoma within 3 months before the enrollment. 3. Are suspected to have other malignancies by chest-abdomen-pelvic contrast CT within 60 days before the enrollment. 4. Are pregnant. 5. Are judged by the study doctor to be ineligible for the study for any other reason.

Design outcomes

Primary

MeasureTime frame
Positive rate of LUNAR assay in advanced colorectal adenoma and stage 0-2 colorectal cancer.

Countries

Japan

Contacts

Public ContactYoshiaki Nakamura

National Cancer Center Hospital East Division for the Promotion of Drug and Diagnostic Development

yoshinak@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026