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

Not Applicable

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000045411
• Lead Sponsor: ational Research and Development Agency, National Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-01
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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