Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05595252

Collaborator

(none)

100

Enrollment

Location

108

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia	Biological: cervical biopsy

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022

Actual Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with CIN lésions during pregnancy	Biological: cervical biopsy cervical biopsy made during and after pregancy

Arm

Intervention/Treatment

Patients with CIN lésions during pregnancy

Biological: cervical biopsy

cervical biopsy made during and after pregancy

Outcome Measures

Primary Outcome Measures

progress, persistence or regression of CIN lesion count [up to one year after delivery]
cervical biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

women who have a CIN lesion during pregnancy
in Nancy, France, MRUN Center
between 2014 and 2022

Exclusion Criteria:

lost of follow up women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BENOIT Camille	Nancy		France	54000

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Principal Investigator: Camille BENOIT, CHRU Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MARTIN Elena, Assistant clinical Director, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05595252

Other Study ID Numbers:

2022PI157/EUDRACT

First Posted:

Oct 26, 2022

Last Update Posted:

Oct 26, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Oct 26, 2022