HyperplasiaNCT01816438
A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia
An observational study of Hyperplasia and Dysplasia, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions. It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperplasia, Dysplasia
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jul 2024
- How long will I take part?
- 4 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In France more than 40000 persons are concerned with a high risk of cancer because of ulcerative colitis for example
Who may be able to join
- intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
- compliant patient
- endoscopic follow possible
- no settler cancer
- no serious pathology such as cancer
Who cannot join
- settler cancer
- serious pathology such as cancer
- no compliant patient
- endoscopic follow not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases
The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.
It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.
Read more
Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).
The main criterion evaluation will be the surgical and endoscopic rates during the time.
The treatments offered such as surgical, endoscopic ones or none of them will be followed.
Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.
Read the detailed description
A replay centralized pathological lesion slides corresponding to the different lesion will be done
- Conditions
- Hyperplasia, Dysplasia
- Keywords
- abnormal histological colorectal lesions
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dysplasia or colorectal lesion | 300 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopies results
rates of surgery and endoscopic treatments frequency of development of a cancer or a high grade dysplasia according to a type of abnormal histological colorectal lesion
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2023
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
- Investigators
- Saurin Jean Christophe, MSD, Principal investigator, no affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816438
- Sponsor's protocol ID
- SFED N°100
- Status last verified
- Sep 2023
- First submitted
- 20 Mar 2013
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT01816438
- Acronym / sponsor ID
- SFED N°100
- Conditions
- Hyperplasia, Dysplasia
- Keywords
- abnormal histological colorectal lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2023 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Mar 2013 (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.
The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.
It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.
Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).
The main criterion evaluation will be the surgical and endoscopic rates during the time.
The treatments offered such as surgical, endoscopic ones or none of them will be followed.
Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.
Detailed description
A replay centralized pathological lesion slides corresponding to the different lesion will be done
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dysplasia or colorectal lesion | – | –300 patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In France more than 40000 persons are concerned with a high risk of cancer because of ulcerative colitis for example
Key inclusion criteria (5 listed)
- intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
- compliant patient
- endoscopic follow possible
- no settler cancer
- no serious pathology such as cancer
Key exclusion criteria (4 listed)
- settler cancer
- serious pathology such as cancer
- no compliant patient
- endoscopic follow not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
endoscopies results
Time frame: 4 years
rates of surgery and endoscopic treatments frequency of development of a cancer or a high grade dysplasia according to a type of abnormal histological colorectal lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Saurin Jean Christophe, MSD principal investigator
no affiliated
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 Hyperplasia and Dysplasia, run by Hôpital Edouard Herriot at 1 site in France.
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 5 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 21 Sep 2023. 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 France. 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?
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?
endoscopies results (time frame: 4 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 21 Sep 2023.