Cervical Intraepithelial NeoplasiaNCT05595252
Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022
An observational study of Cervical Intraepithelial Neoplasia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive. Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- cervical biopsy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 31 Dec 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: study on patients who were pregnant and have a CIN lesion at the same time, care at the MRUN, the Nancy Régional Maternity between 2014 and 2022
Who may be able to join
- women who have a CIN lesion during pregnancy
- in Nancy, France, MRUN Center
- between 2014 and 2022
Who cannot join
- lost of follow up women
Trial locations and contacts
1 site in 1 country.
About this study
In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive.
Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist.
Read more
The cervical smear is therefore an important step of the first consultation during pregnancy In the case of pathological results, colposcopies with biopsies are performed, frequently finding CIN 1 to 3. (cervical intraepithelial neoplasia) These CIN lesions evolve slowly and most of the time, treatment can be withheld until the end of the pregnancy.
Several studies suggest a higher regression rate in pregnant patients. Our study will evaluate the rate of regression, progression or persistence of these lesions in per and post partum patients in Nancy, between 2014 and 2022.
To obtain our results, we will compare the results of per and post partum biopsies in each patient.
In a second step, we will study the risk factors of aggravation or on the contrary the protective factors, allowing a faster regression of the lesions
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- cervical biopsy
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical biopsyBiological
cervical biopsy made during and after pregancy
| Study group | Role | What they receive |
|---|---|---|
| Patients with CIN lésions during pregnancy | Not described Receives: Biological: cervical biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress, persistence or regression of CIN lesion count
cervical biopsy
Measured: up to one year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Jan 2014
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARTIN Elena, Central Hospital, Nancy, France
- Investigators
- Camille BENOIT, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595252
- Sponsor's protocol ID
- 2022PI157/EUDRACT
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 26 Oct 2022
- 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 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022
- ClinicalTrials.gov ID
- NCT05595252
- Acronym / sponsor ID
- 2022PI157/EUDRACT
- Conditions
- Cervical Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Oct 2022 (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.
In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive.
Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist.
The cervical smear is therefore an important step of the first consultation during pregnancy In the case of pathological results, colposcopies with biopsies are performed, frequently finding CIN 1 to 3. (cervical intraepithelial neoplasia) These CIN lesions evolve slowly and most of the time, treatment can be withheld until the end of the pregnancy.
Several studies suggest a higher regression rate in pregnant patients. Our study will evaluate the rate of regression, progression or persistence of these lesions in per and post partum patients in Nancy, between 2014 and 2022.
To obtain our results, we will compare the results of per and post partum biopsies in each patient.
In a second step, we will study the risk factors of aggravation or on the contrary the protective factors, allowing a faster regression of the lesions
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CIN lésions during pregnancy | – | Biological: cervical biopsy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- study on patients who were pregnant and have a CIN lesion at the same time, care at the MRUN, the Nancy Régional Maternity between 2014 and 2022
Key inclusion criteria (3 listed)
- women who have a CIN lesion during pregnancy
- in Nancy, France, MRUN Center
- between 2014 and 2022
Key exclusion criteria (1 listed)
- lost of follow up women
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 |
|---|---|---|
| cervical biopsycervical biopsy made during and after pregancy | Biological | Patients with CIN lésions during pregnancy |
Primary outcome
progress, persistence or regression of CIN lesion count
Time frame: up to one year after delivery
cervical biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
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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.
Camille BENOIT principal investigator
CHRU 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 Cervical Intraepithelial Neoplasia, 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 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. 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?
progress, persistence or regression of CIN lesion count (time frame: up to one year after delivery). 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 Oct 2022.