Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

NCT04369339 | Completed

• 1 other identifier: OHRHPVCOLP
• Study Type: interventional
• Target: 185
• Locations: 0 countries
• Sites: N/A

Brief Summary

Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes

Conditions

Human Papillomavirus Infection

Keywords

Human Papilloma Virus; negative for intraepithelial lesions or malignancy; HPV16; HPV18

Outcome Measures

Primary Outcomes (1)

• Dysplasia

  Pathologic diagnosis of cervical dysplasia

  1 month

Study Arms (2)

Other High Risk HPV Positivity

EXPERIMENTAL

Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology

Other: Colposcopy

HPV16/18

ACTIVE COMPARATOR

Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology

Other: Colposcopy

Interventions

Colposcopy OTHER

HPV16/18; Other High Risk HPV Positivity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive HrHPV test other than HPV 16 or HPV 18

You may not qualify if:

• Previous diagnosis for cervical cancer Previous diagnosis for vaginal cancer Previous diagnosis for cervical dysplasia Previous diagnosis for ASCUS previous history of cervical conisation or hysterectomy previous history ofhysterectomy

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Papillomavirus Infections; Neoplasms

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessor blind to clinical data and cytology results
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: June 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share