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出境医 / 临床实验 / Treatment Response Prediction System of mCRC Patients Based on CTC

Treatment Response Prediction System of mCRC Patients Based on CTC

Study Description
Brief Summary:
This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.

Condition or disease Intervention/treatment
Colorectal Cancer Stage IV Circulating Tumor Cell Diagnostic Test: Circulating tumor cell

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells
Estimated Study Start Date : June 15, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2025
Arms and Interventions
Group/Cohort Intervention/treatment
Training Group
The training cohort that used to built the response prediction model
 Diagnostic Test: Circulating tumor cell
Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)
Validation Group
The validation cohort that used to validate the response prediction model
 Diagnostic Test: Circulating tumor cell
Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)
Outcome Measures
Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 1 year ]
    The sensitivity of the response prediction model

  2. Specificity [ Time Frame: 1 year ]
    The specificity of the response prediction model


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy
Criteria

Inclusion Criteria:

  • Age 18-80 years;

histologically proven colorectal liver metastasis

With liver-dominant disease (extrahepatic metastases limited to lung metastases)

ECOG 0-1

A life expectancy of ≥ 3 months

Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3

Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl

Written informed consent for participation in the trial.

Exclusion Criteria:

  • Other previous malignancy within 5 years

Have metastases other than liver and lung metastases

Receiving any treatment before first blood collection

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jianmin Xu +8613501984869 xujmin@aiiyun.com

Sponsors and Collaborators
Fudan University
Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 8, 2021
Estimated Study Start Date June 15, 2021
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2021)
  • Sensitivity [ Time Frame: 1 year ]
    The sensitivity of the response prediction model
  • Specificity [ Time Frame: 1 year ]
    The specificity of the response prediction model
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Response Prediction System of mCRC Patients Based on CTC
Official Title Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells
Brief Summary This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy
Condition
  • Colorectal Cancer Stage IV
  • Circulating Tumor Cell
Intervention Diagnostic Test: Circulating tumor cell
Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)
Study Groups/Cohorts
  • Training Group
    The training cohort that used to built the response prediction model
    Intervention: Diagnostic Test: Circulating tumor cell
  • Validation Group
    The validation cohort that used to validate the response prediction model
    Intervention: Diagnostic Test: Circulating tumor cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 2, 2021) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2025
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 18-80 years;

histologically proven colorectal liver metastasis

With liver-dominant disease (extrahepatic metastases limited to lung metastases)

ECOG 0-1

A life expectancy of ≥ 3 months

Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3

Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl

Written informed consent for participation in the trial.

Exclusion Criteria:

  • Other previous malignancy within 5 years

Have metastases other than liver and lung metastases

Receiving any treatment before first blood collection
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jianmin Xu +8613501984869 xujmin@aiiyun.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04917276
Other Study ID Numbers ZSCTC2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fudan University
Study Sponsor Fudan University
Collaborators Not Provided
Investigators Not Provided
PRS Account Fudan University
Verification Date April 2021