Study of Risk Factors for IPMNs Degeneration at the Nancy CHRUIPMNNCT04901364
Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)
An observational study of Study of Risk Factors for IPMNs Degeneration at the Nancy CHRU, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis. IPMNs require characterization to clarify their potential for degeneration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Study of Risk Factors for IPMNs Degeneration at the Nancy CHRU
- What is being tested?
- Sensitivity and specificity of risk factors for degeneration of IPMNs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2021to 30 Oct 2021
- 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: Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021
Who may be able to join
- Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021, adults and without legal protection measures
Who cannot join
- IPMNs not operated
- Pancreatic cancer without IPMNs
- Patients whose state of health contraindicates pancreatic surgery
- Non-adult patient
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Jean-Baptiste CHEVAUX
Nancy, 54000
Jean Baptiste JC CHEVAUX, 0677066140, jb.chevaux@chru-nancy.fr
Remy RF FONTANIE, 0616297216, r.fontanie@chru-nancy.fr
About this study
Official title: Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)
Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.
IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.
Pancreatic surgery remains invasive with high morbidity and mortality rates.
Read the detailed description
This is a monoservice and monocentric retrospective study at the Nancy CHRU. We will study the risk factors for IPMNs degeneration in order to determine the most sensitive and specific.
To do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint.
The study population will be patients with Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021.
- Being tested
- Sensitivity and specificity of risk factors for degeneration of IPMNs
- Keywords
- IPMNs, Intraductal Papillary Mucinous Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitivity and specificity of risk factors for degeneration of IPMNsBehavioural
Measurement of high-grade dysplasia or invasive cancer on the histological analysis of the surgical specimen
What is being measured
The primary outcome is the main question the study is designed to answer.
High-grade dysplasia or invasive cancer
High-grade dysplasia or invasive cancer on histological analysis of the surgical specimen
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start10 May 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study of Risk Factors for IPMNs Degeneration at the Nancy CHRUStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Baptiste CHEVAUX, Central Hospital, Nancy, France
- Investigators
- Jean Baptiste JC CHEVAUX, Principal investigator, Centre Hospitalier Regional Universitaire de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901364
- Sponsor's protocol ID
- 2021PI064
- Acronym
- IPMN
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)
- ClinicalTrials.gov ID
- NCT04901364
- Acronym / sponsor ID
- IPMN / 2021PI064
- Keywords
- IPMNs, Intraductal Papillary Mucinous Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 25 May 2021 (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.
Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.
IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.
Pancreatic surgery remains invasive with high morbidity and mortality rates.
Detailed description
This is a monoservice and monocentric retrospective study at the Nancy CHRU. We will study the risk factors for IPMNs degeneration in order to determine the most sensitive and specific.
To do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint.
The study population will be patients with Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021
Key inclusion criteria (1 listed)
- Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021, adults and without legal protection measures
Key exclusion criteria (5 listed)
- IPMNs not operated
- Pancreatic cancer without IPMNs
- Patients whose state of health contraindicates pancreatic surgery
- Non-adult patient
- Patients under legal protection
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 |
|---|---|---|
| Sensitivity and specificity of risk factors for degeneration of IPMNsMeasurement of high-grade dysplasia or invasive cancer on the histological analysis of the surgical specimen | Behavioural | – |
Primary outcome
High-grade dysplasia or invasive cancer
Time frame: 12 years
High-grade dysplasia or invasive cancer on histological analysis of the surgical specimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- 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.
Jean Baptiste JC CHEVAUX principal investigator
Centre Hospitalier Regional Universitaire de Nancy
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 Study of Risk Factors for IPMNs Degeneration at the Nancy CHRU, run by Central Hospital, Nancy, France 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 1 inclusion and 5 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 25 May 2021. 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?
Contact Remy RF FONTANIE (0616297216, remyfontanie@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-grade dysplasia or invasive cancer (time frame: 12 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 25 May 2021.