Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT07211204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population
Sponsor:
Timser SAPI de CV
Organization:
Study Overview
Official Title:
Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares the efficacy of cytology (Pap smear) with the molecular screening in their ability to detect reactive cellular changes in the cervix among an open population
Detailed Description:
The primary goal of this study is to compare the efficacy of the cytology (Pap smear) with the molecular screening -of three human biomarkers- in their ability to detect reactive cellular changes in the cervix among an open population. Participants will be asked to attend two study visits. All the clinical procedures will be done on the first visit:
1. Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.
2. Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.
3. Venipuncture to obtain a blood sample.
4. Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.
5. Biopsy, only if the gynecologist detects a cervical lesion or another abnormality during colposcopy.
The gynecologist will make preliminary recommendations based on the colposcopic findings.
During the second visit the study's gynecologist will explain the tests' results and provide clinical recommendations to each participant.
The sensitivity, specificity, and predictive values of cytology, HPV detection, and molecular screening will be calculated using colposcopy (for all participants) and histopathology (for those biopsied). These results will be compared using a DeLong test. Correlation tests will be performed using risk factors data and test results.
1. Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.
2. Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.
3. Venipuncture to obtain a blood sample.
4. Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.
5. Biopsy, only if the gynecologist detects a cervical lesion or another abnormality during colposcopy.
The gynecologist will make preliminary recommendations based on the colposcopic findings.
During the second visit the study's gynecologist will explain the tests' results and provide clinical recommendations to each participant.
The sensitivity, specificity, and predictive values of cytology, HPV detection, and molecular screening will be calculated using colposcopy (for all participants) and histopathology (for those biopsied). These results will be compared using a DeLong test. Correlation tests will be performed using risk factors data and test results.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-EXT-886 | OTHER | Ethics Committee of Medica Sur | View |