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Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787667
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Guoxiang Cai, Fudan University

Brief Summary:
This is a prospective, clinical study. This study is to collect and analyze data of radiomics of primary site or metastasis of colorectal cancer aiming to precisizing preoperative diagnosis and long-term prognsis evaluation.

Condition or disease Intervention/treatment
Colorectal Cancer Stage I-IV Diagnostic Test: CT or MRI based Radiomics

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with pathologically diagnosed colorectal cancer
Patients with pathologically diagnosed colorectal cancer
Diagnostic Test: CT or MRI based Radiomics
Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.




Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 2 years ]
    The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients received enhaced CT or MRI test must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
Criteria

Inclusion Criteria:

  • Patients with pathologically confirmed colorectal cancer
  • Male or female aged 18-75 years old on the day of signing informed consent.
  • Patients who received imageological examination of primary or metastasis
  • Patients who received surgical resection of primary or metastasis
  • Patients must have a performance status of ≤1 on the ECOG Performance Scale.
  • Colorectal cancer is the only malignant tumor
  • Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study

Exclusion Criteria:

  • Patients received adjuvant treatment prior to imageological examination
  • Tis stage patients
  • Paitents who diagnosed with malignant disease within 5 years.
  • Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787667


Contacts
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Contact: Guoxiang Cai, M.D.Ph.D. +86 13611831623 gxcai@fudan.edu.cn

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Guoxiang Cai    +8613611831623 ext +8613611831623    gxcai@fudan.edu.cn   
Sponsors and Collaborators
Fudan University

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Responsible Party: Guoxiang Cai, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03787667     History of Changes
Other Study ID Numbers: ColoRadiomics
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases