Skip to content

A study to determine whether detection of tumor-derived DNA in the blood of patients with colorectal cancer with liver metastases can be useful for early detection of recurrence of the disease

Clinical utility of circulating tumor DNA to detect early tumor recurrence after surgery in patients with radically resectable liver metastases from colorectal cancer: a single institute prospective observational study - CASSIOPEIA study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057128
Enrollment
10
Registered
2025-03-01
Start date
2024-11-06
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

patients with resectable liver metastases from colorectal cancer

Interventions

None listed

Sponsors

Osaka General Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histological Diagnosis: Histopathologically confirmed adenocarcinoma of colorectal cancer. 2. Primary Tumor Location and Resection: The primary tumor is located in the colon (cecum, colon, sigmoid rectum) or rectum and has been resected. Appendiceal and anal canal cancers are excluded. 3. Liver Metastases: No distant metastases other than liver metastases, and curative hepatectomy is planned for the first time. Cases involving systemic chemotherapy enabling curative liver resection (conversion therapy) are also eligible. 4. Age: 20 years or older at the time of consent acquisition. 5. Performance Status: ECOG PS of 0 or 1. 6. Informed Consent: Written informed consent for study participation was obtained from the patient.

Exclusion criteria

Exclusion criteria: 1. Active Double Cancer: Active overlapping cancers at the time of hepatectomy. Exceptions include: (a) relapse-free period of more than 5 years, (b) localized cancers cured through local treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, ductal carcinoma in situ, or mucosal carcinoma), or (c) non-metastatic prostate cancer not requiring systemic treatment. 2. Pregnancy or Breastfeeding: Pregnancy or lactation at the time of the study. 3. Serious Complications: Patients with severe comorbidities that could affect the safety or proper implementation of the study. 4. Viral Infections: Positive for HBs antigen, HCV antibody, or HIV antibody. 5. Medical Inappropriateness: Deemed unsuitable for the study by the attending physician.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the interval between the detection of ctDNA positivity and the clinical diagnosis of recurrence.

Countries

Japan

Contacts

Public ContactAkira Inoue

Osaka General Medical Center Department of Gastroenterological Surgery

inoue_medical@yahoo.co.jp06-6692-1201

Outcome results

None listed

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