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Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion

Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion - Observational study to investigate the correlations between the circulating tumor DNA and clinicopathological features of metastatic lesion

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000045411
Enrollment
100
Registered
2021-10-01
Start date
2021-11-01
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

colorectal cancer

Interventions

None listed

Sponsors

National Research and Development Agency, National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligibility criteria for the prospective cohort 1. Patients with colorectal cancer diagnosed with lung or liver metastases 2. Computed tomography (CT) scan performed within 60 days of registration 3. Patients who plan to undergo resection of lung metastasis with curative intent 4. Resection with curative intent is performed to remove primary lesions 5. 20 years or older at the time of obtaining informed consent 6. Provides written informed consent to participate in this study Eligibility criteria for the retrospective cohort 1. Patients with colorectal cancer diagnosed with lung or liver metastases 2. Prior to biobank blood sampling, resection with curative intent was performed to remove the primary lesion 3. Interval from biobank blood sampling to excision of metastatic sites was less than 90 days 4. Those who have undergone curative resection of metastasis to other organs during the study period* *Two-stage resection is acceptable in patients who have undergone curative resection. 5. Comprehensive consent for the use of surplus medical samples was obtained from the National Cancer Center.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the prospective cohort 1. Active overlapping cancers noted at the time of curative resection. However, patients with a recurrence-free period of at least 5 years; those with basal cell carcinoma or spinous cell carcinoma of the skin that was eventually cured after receiving local treatment; and those with superficial bladder cancer, cervical cancer, carcinoma in situ, intramucosal cancer (that can be treated endoscopically), and nonmetastatic prostate cancer (that does not require systematic treatment) can be registered. 2. Pre-operative treatment (chemotherapy, radiation therapy, immunotherapy) is administered or planned prior to metastasis resection Exclusion criteria for the retrospective cohort 1. Active overlapping cancers noted at the time of curative resection. *However, patients with a recurrence-free period of at least 5 years or those with basal cell carcinoma or spinous cell carcinoma of the skin that was eventually cured by local treatment, superficial bladder cancer, cervical cancer, carcinoma in situ (that can be treated endoscopically), and nonmetastatic prostate cancer (that does not require systematic treatment) can be registered. 2. Pre-operative treatment (chemotherapy, radiation therapy, immunotherapy) was administered prior to the curative resection of metastases. **Adjuvant chemotherapy administered prior to the appearance of metastases is acceptable.

Design outcomes

Primary

MeasureTime frame
Correlations between pathological features and status of ctDNA detection in tissue samples of metastatic organs Correlations between ctDNA detection status and clinical information, including radiological images Significance of exosome analysis in cases in which ctDNA is difficult to detect

Countries

Japan

Contacts

Public ContactHiroki Yukami

National Cancer Center Hospital East Department of Gastroenterology and Gastrointestinal Oncology

hyukami@east.ncc.go.jp04-7333-1111

Outcome results

None listed

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