Colorectal Cancer Stage I-IVNCT03787667
Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.
An observational study of Colorectal Cancer Stage I-IV, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Stage I-IV
- What is being tested?
- CT or MRI based Radiomics
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guoxiang Cai, +8613611831623 ext. +8613611831623, gxcai@fudan.edu.cn
About this study
Official title: Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study
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.
- Conditions
- Colorectal Cancer Stage I-IV
- Being tested
- CT or MRI based Radiomics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT or MRI based RadiomicsDiagnostic test
Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pathologically diagnosed colorectal cancer | Patients with pathologically diagnosed colorectal cancer Receives: Diagnostic Test: CT or MRI based Radiomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 May 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage I-IVStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787667
- Sponsor's protocol ID
- ColoRadiomics
- Status last verified
- Dec 2018
- First submitted
- 22 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study
- ClinicalTrials.gov ID
- NCT03787667
- Acronym / sponsor ID
- ColoRadiomics
- Conditions
- Colorectal Cancer Stage I-IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pathologically diagnosed colorectal cancer | – | Diagnostic Test: CT or MRI based RadiomicsPatients with pathologically diagnosed colorectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT or MRI based RadiomicsRadiomic features were extracted from enhanced CT or MRI of colorectal cancer. | Diagnostic test | Patients with pathologically diagnosed colorectal cancer |
Primary outcome
Sensitivity
Time frame: 2 years
The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Stage I-IV, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoxiang Cai, M.D.Ph.D. (+86 13611831623, gxcai@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.