Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of CTC
1 other identifier
observational
1,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 3, 2021
April 1, 2021
2.5 years
June 2, 2021
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity
The sensitivity of the predictive based on the number and type of circulating tumor cell
1 year
Specificity
The specificity of predictive model based on the number and type of circulating tumor cell
1 year
Secondary Outcomes (1)
AUC
1 year
Study Arms (2)
Training Group
Training group including about 500 patients that be using to building the prognosis model
Validation Group
Validation group including about another 500 patients that be using to validating the prognosis model
Interventions
detecting circulating tumor cell pre- and post operatively
Eligibility Criteria
I-IV stage colorectal cancer patients with resectable lesion(s) who not receive preoperative treatment
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 3, 2021
Study Start
June 15, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2025
Last Updated
June 3, 2021
Record last verified: 2021-04