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出境医 / 临床实验 / Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients
Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients
Study Description
Brief Summary:
The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Colon Cancer | Device: Magnetic resonance imaging | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique |
| Actual Study Start Date : | February 7, 2019 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | July 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Magnetic resonance imaging
Annual MRI during 3 years
|
Device: Magnetic resonance imaging
Annually magnetic resonance imaging
|
Outcome Measures
Primary Outcome Measures :
- Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI. [ Time Frame: 3 years ]Diagnostic of brain metastases on annual MRI
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologically proven colorectal adenocarcinoma
- Metastases from colorectal cancer diagnosed since less than 6 months
- Indication of an oncologic treatment
Exclusion Criteria:
- Patient with contraindication for MRI
- Diagnosis of cancer other than colorectal cancer in the last three years, except in situ cancers, basal-cell skin cancer or squamous-cell skin cancer, and other cancer with low risk of brain dissemination according to the investigator
- Pregnant or breastfeeding women, women of childbearing potential without effective contraception
Contacts and Locations
Contacts
| Contact: David TOUGERON, MD, PhD | 0549443751 ext +33 | david.tougeron@chu-poitiers.fr |
Locations
| France | |
| C.H.U. de Poitiers | Recruiting |
| Poitiers, France, 86000 | |
| Contact: David Tougeron, MD david.tougeron@chu-poitiers.fr | |
Sponsors and Collaborators
Poitiers University Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | October 2, 2018 | ||||
| First Posted Date ICMJE | October 3, 2018 | ||||
| Last Update Posted Date | November 17, 2020 | ||||
| Actual Study Start Date ICMJE | February 7, 2019 | ||||
| Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI. [ Time Frame: 3 years ] Diagnostic of brain metastases on annual MRI
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients | ||||
| Official Title ICMJE | Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique | ||||
| Brief Summary | The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Screening |
||||
| Condition ICMJE | Metastatic Colon Cancer | ||||
| Intervention ICMJE | Device: Magnetic resonance imaging
Annually magnetic resonance imaging
|
||||
| Study Arms ICMJE | Experimental: Magnetic resonance imaging
Annual MRI during 3 years
Intervention: Device: Magnetic resonance imaging
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
200 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 2024 | ||||
| Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03694938 | ||||
| Other Study ID Numbers ICMJE | DEMECIA | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Poitiers University Hospital | ||||
| Study Sponsor ICMJE | Poitiers University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Poitiers University Hospital | ||||
| Verification Date | November 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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