Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of CTC

Not yet recruiting

• Conditions: Colorectal Cancer; Circulating Tumor Cell
• Interventions: Diagnostic Test: Circulating tumor cell

• Registration Number: NCT04912882
• Lead Sponsor: Fudan University

Brief Summary

Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Study Start: 2021-06-15
• Primary Completion: 2023-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age 18-80 years;

Histologically proven colorectal carcinoma (TNM stage I-IV)

R0 resection is possible according to preoperative evaluation

Written informed consent for participation in the trial.

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Exclusion Criteria

• Primary tumor or metastases not able to be removed radically

Receiving any preoperative treatment (Including chemotherapy, radiotherapy and target therapy)

Have other malignant tumors meanwhile

Other previous malignancy within 5 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training Group	Circulating tumor cell	Training group including about 500 patients that be using to building the prognosis model
Validation Group	Circulating tumor cell	Validation group including about another 500 patients that be using to validating the prognosis model

Primary Outcome Measures

Name	Time	Method
Specificity	1 year	The specificity of predictive model based on the number and type of circulating tumor cell
Sensitivity	1 year	The sensitivity of the predictive based on the number and type of circulating tumor cell

Secondary Outcome Measures

Name	Time	Method
AUC	1 year	Area under curve of the predictive model