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

Colorectal Cancer Clinical Trial

Official title:

Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of Circulating Tumor Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04912882
• Other study ID #: ZSCTC1
• Status: Not yet recruiting
• Start date: June 15, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2021
• Source: Fudan University
• Contact: Jianmin Xu
• Phone: +8613501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colorectal Cancer
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• Circulating tumor cell
detecting circulating tumor cell pre- and post operatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	The sensitivity of the predictive based on the number and type of circulating tumor cell	1 year
Primary	Specificity	The specificity of predictive model based on the number and type of circulating tumor cell	1 year
Secondary	AUC	Area under curve of the predictive model	1 year