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

June 2, 2021 updated by: Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

I-IV stage colorectal cancer patients with resectable lesion(s) who not receive preoperative treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training Group
Training group including about 500 patients that be using to building the prognosis model
Diagnostic test: Circulating tumor cell
detecting circulating tumor cell pre- and post operatively
Validation Group
Validation group including about another 500 patients that be using to validating the prognosis model
Diagnostic test: Circulating tumor cell
detecting circulating tumor cell pre- and post operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 1 year
The sensitivity of the predictive based on the number and type of circulating tumor cell
1 year
Specificity
Time Frame: 1 year
The specificity of predictive model based on the number and type of circulating tumor cell
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 1 year
Area under curve of the predictive model
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSCTC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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