ReadyMix Lite Clinical Trial for Detection of Human Papillomavirus DNA as a Cervical Cancer Screening Method in Urine and Cervical Swab Samples.
Tahapan Penelitian : Initial
Sponsor:
PT. Riset Nusantara Genetika
Mitra Pelaksana:
RSUD Dr. Soetomo Surabaya
No Registry
INA-1FONMRLK
Tanggal Input Registry : 18-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-03-2025 |
| Outcome Primer | - Determining the diagnostic performance of ReadyMix Lite to detect Human Papillomavirus DNA in cervical swab samples based on parameters such as sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and level of agreement calculated based on comparison with the detection results by PathoScan hrHPV qPCR Kit - Determining the diagnostic performance of ReadyMix Lite to detect Human Papillomavirus DNA in urine samples based on parameters such as sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and level of agreement calculated based on comparison with the detection results by PathoScan hrHPV qPCR Kit - Comparing the hrHPV genotyping results obtained by ReadyMix Lite and PathoScan hrHPV qPCR Kit in cervical swab and urine samples |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | ReadyMix Lite Clinical Trial for Detection of Human Papillomavirus DNA as a Cervical Cancer Screening Method in Urine and Cervical Swab Samples. |
| Judul Penelitian Ilmiah | ReadyMix Lite Clinical Trial for Detection of Human Papillomavirus DNA as a Cervical Cancer Screening Method in Urine and Cervical Swab Samples. |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 500 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Women aged 20 to 50 years - Ever been or are currently sexually active/ are in a high-risk group for cervical cancer/ are referred for cervical cancer screening/ have been diagnosed positive for hrHPV/ are confirmed to have CIN2+ (CIN2/CIN3/cervical cancer) based on expert review a maximum of 3 months before sampling and have not received treatment/care. - Willing to participate in the study and sign the Informed Consent FormExclusion Criteria: - Subjects are not willing to participate in the study - Samples obtained do not meet the requirements - Pregnant women (based on anamnesis) - Suffering from HIV infection (based on anamnesis & medical history) - Menstruating/postpartum - Have received complete HPV vaccination. - Having sexual intercourse/vaginal cleaning with cleaning fluid/using vaginal medicine/foam/cream/spermicidal jelly/using tampons since two days before the test - Forcing urination by drinking excessive water before sampling |
| Administrative Information | |
| Nomor Persetujuan Etik | 1209/KEPK/I/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | dr. Khoirunnisa Novitasari, Sp.OG |