DMBT1 Protein, HumanDMBT1NCT02901600
Expression of DMBT1 in Colorectal Cancer Patients
An observational study of DMBT1 Protein, Human and Colorectal Cancer, run by Lille Catholic University.
Trial summary
Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DMBT1 Protein, Human, Colorectal Cancer
- What is being tested?
- Detection of the expression of DMTB1 by immunohistochemistry
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with colorectal carcinoma, with polyps or without colonic pathology
Who may be able to join
- for colon cancer: patients surgically treated for colorectal cancer at the Group of hospitals of the Catholic Institute of Lille.
- for adenomatous polyps : patients treated for adenomatous polyps at the Group of hospitals of the Catholic Institute of Lille.
- for controls: patients surgically treated for diverticular disease at the Group of hospitals of the Catholic Institute of Lille.
Who cannot join
- none
About this study
Official title: Modification of the Expression and the Localization of DMBT1 (Deleted in Malignant Brain Tumor 1) in Colorectal Cancer
Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease.
Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.
- Conditions
- DMBT1 Protein, Human, Colorectal Cancer
- Being tested
- Detection of the expression of DMTB1 by immunohistochemistry
- Keywords
- DMBT1 expression, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of the expression of DMTB1 by immunohistochemistryOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer | Fresh tissue samples from individuals with colorectal carcinoma taken from the tumor as well as from resection margins will be used for the detection of a potential marker of carcinogenesis. Receives: Other: Detection of the expression of DMTB1 by immunohistochemistry | |
| Patients with adenomatous polyps | Fresh tissue samples from individuals with adenomatous polyps will be used for the detection of a potential marker of carcinogenesis. Receives: Other: Detection of the expression of DMTB1 by immunohistochemistry | |
| Control patients | Fresh tissue samples from individuals without colorectal carcinoma will be used as control. Receives: Other: Detection of the expression of DMTB1 by immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-quantitative determination of the histological expression of DMBT1
The expression of DMTB1 will be determined by observation of the slides after immunohistochemistry using an anti-DMBT1 antibody
Measured: at baseline
Determination of the histological localisation of DMBT1
The localisation of DMTB1 will be determined by observation of slides after immunohistochemistry using an anti-DMBT1 antibody
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMBT1 Protein, HumanStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Mihalache, MD, PhD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901600
- Sponsor's protocol ID
- RT-06
- Acronym
- DMBT1
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of the Expression and the Localization of DMBT1 (Deleted in Malignant Brain Tumor 1) in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02901600
- Acronym / sponsor ID
- DMBT1 / RT-06
- Conditions
- DMBT1 Protein, Human, Colorectal Cancer
- Keywords
- DMBT1 expression, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease.
Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer | – | Other: Detection of the expression of DMTB1 by immunohistochemistryFresh tissue samples from individuals with colorectal carcinoma taken from the tumor as well as from resection margins will be used for the detection of a potential marker of carcinogenesis. |
| Patients with adenomatous polyps | – | Other: Detection of the expression of DMTB1 by immunohistochemistryFresh tissue samples from individuals with adenomatous polyps will be used for the detection of a potential marker of carcinogenesis. |
| Control patients | – | Other: Detection of the expression of DMTB1 by immunohistochemistryFresh tissue samples from individuals without colorectal carcinoma will be used as control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with colorectal carcinoma, with polyps or without colonic pathology
Key inclusion criteria (3 listed)
- for colon cancer: patients surgically treated for colorectal cancer at the Group of hospitals of the Catholic Institute of Lille.
- for adenomatous polyps : patients treated for adenomatous polyps at the Group of hospitals of the Catholic Institute of Lille.
- for controls: patients surgically treated for diverticular disease at the Group of hospitals of the Catholic Institute of Lille.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Detection of the expression of DMTB1 by immunohistochemistry | Other | Control patients, Patients with adenomatous polyps, Patients with colorectal cancer |
Primary outcome
Semi-quantitative determination of the histological expression of DMBT1
Time frame: at baseline
The expression of DMTB1 will be determined by observation of the slides after immunohistochemistry using an anti-DMBT1 antibody
Determination of the histological localisation of DMBT1
Time frame: at baseline
The localisation of DMTB1 will be determined by observation of slides after immunohistochemistry using an anti-DMBT1 antibody
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: No
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.
Adriana Mihalache, MD, PhD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
An observational study of DMBT1 Protein, Human and Colorectal Cancer, run by Lille Catholic University.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-quantitative determination of the histological expression of DMBT1 (time frame: at baseline). The study lists 2 primary outcomes in all. 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 15 Sep 2016.