Two self-sampling methods (Vaginal dry swabs vs. FTA-elute cartridge) for HPV detection.

Randomized comparison of two self-sampling methods (Vaginal dry swabs vs. FTA-elute cartridge) for HPV detection.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43310942

Enrollment

130

Registered

2015-05-22

Start date

2014-03-01

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical pre-cancer and cancer. Cancer

Interventions

Women were invited to perform two self-sampling (FTA and v-DRY). Randomization of the sequence of the two self-HPV tests was done to avoid potential bias that may advantage the “first” test. The rese

Copan, Italy). Recommendations were to hold the brush/swab by the end of the handle, to insert the brush/swab into the vagina, avoiding contact with the external genitalia, until they meet resistance

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. At least 30 years old 2. Attending colposcopy clinic 3. Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Previous Hysterectomy 3. Virgin 4. Not able to comply with protocol study

Design outcomes

Primary

Measure	Time frame
Agreement between collection methods in terms of HPV positivity, measured using kappa statistic and corresponding standard deviation.	—

Secondary

Measure	Time frame
1. Sensitivity and specificity to detect high-risk HPV using the result from the physician’s collected samples as gold standard was reported, as well as, sensitivity and specificity of the three sampling methods for abnormal Pap smear. Because of the small number of high-grade squamous intraepithelial lesion (HSIL) or carcinomas in our population, we assessed sensitivity and specificity for low-grade squamous intraepithelial lesion or greater lesions (LSIL+). The two-tailed McNemar’s test was used for mutual comparison of sensitivity and specificity. 2. Positive and negative predictive values to detect high-risk HPV using the physician’s collected samples as gold standard 3. Positive and negative predictive values of the three sampling methods to detect high-risk HPV for abnormal Pap smear results 4. Agreement between collection methods in terms of HPV positivity, according to cytological results Agreement between collection methods according to cytological results was measured using kappa statistic and corresponding standard deviation 5. Proportion of positive agreement (PPA) between paired FTA and Vaginal dry swabs (v-DRY) samples. The proportion of positive agreement (PPA) between paired FTA and v-DRY samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both dry samples, f1=the number of samples that were positive for FTA and g1=the number of samples that were positive for v-DRY 6. Proportion of positive agreement (PPA) between paired self collection methods (combined results of FTA and v-DRY) and physician’s collected sample. The proportion of positive agreement (PPA) between paired self collection methods and physician’s collected samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both samples, f1=the number of samples that were positive for the self-collection methods and g1=the number of samples that were pos	—

Measure

Time frame

1. Sensitivity and specificity to detect high-risk HPV using the result from the physician’s collected samples as gold standard was reported, as well as, sensitivity and specificity of the three sampling methods for abnormal Pap smear. Because of the small number of high-grade squamous intraepithelial lesion (HSIL) or carcinomas in our population, we assessed sensitivity and specificity for low-grade squamous intraepithelial lesion or greater lesions (LSIL+). The two-tailed McNemar’s test was used for mutual comparison of sensitivity and specificity. 2. Positive and negative predictive values to detect high-risk HPV using the physician’s collected samples as gold standard 3. Positive and negative predictive values of the three sampling methods to detect high-risk HPV for abnormal Pap smear results 4. Agreement between collection methods in terms of HPV positivity, according to cytological results Agreement between collection methods according to cytological results was measured using kappa statistic and corresponding standard deviation 5. Proportion of positive agreement (PPA) between paired FTA and Vaginal dry swabs (v-DRY) samples. The proportion of positive agreement (PPA) between paired FTA and v-DRY samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both dry samples, f1=the number of samples that were positive for FTA and g1=the number of samples that were positive for v-DRY 6. Proportion of positive agreement (PPA) between paired self collection methods (combined results of FTA and v-DRY) and physician’s collected sample. The proportion of positive agreement (PPA) between paired self collection methods and physician’s collected samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both samples, f1=the number of samples that were positive for the self-collection methods and g1=the number of samples that were pos

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026