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

NCT ID: NCT04912882

Last Updated: 2021-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Colorectal Cancer Circulating Tumor Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training Group

Training group including about 500 patients that be using to building the prognosis model

Circulating tumor cell

Intervention Type DIAGNOSTIC_TEST

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

Circulating tumor cell

Intervention Type DIAGNOSTIC_TEST

detecting circulating tumor cell pre- and post operatively

Interventions

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Circulating tumor cell

detecting circulating tumor cell pre- and post operatively

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jianmin Xu

Role: CONTACT

+8613501984869

Other Identifiers

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ZSCTC1

Identifier Type: -

Identifier Source: org_study_id

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