Clinical trial · Interventional
Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is 1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer. 2. If HPV DNA is not a promising biomarker, other biomarkers will be explored. 3. To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation. The main question it aims to answer is: To validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancer Participants will 1. Join the briefing session of the study 2. Sign the consent form and health questionnaire 3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test 4. Collect the urine sample If there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collect HPV DNA from urine | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Collect HPV DNA from urine
- interventionNames
- Diagnostic Test: Collect HPV DNA from urine
Primary outcomes (1)
- measure
- HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer
- timeFrame
- From enrollment to sample analysis, 1month
- description
- Briefly, in order to concentrate all DNA, including cell free DNA fragments, gDNA extraction kit (Solarbio) will be used according to the manufacturer's instructions. Real time- polymerase chain reaction or multiple assays will be carried out using designed primers of HPV types. Primers for endogenous control are included to control DNA quality.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged between 18 to 65 * Have menstruation * Had sex before * Can read and write Chinese/ English * Without taking any medication (Except nutritional supplements, traditional Chinese medicine, and health care products etc.) Exclusion Criteria: • Subjects who used medication will be excluded from the sample collection. Moreover, subjects with visible signs of gynarcological infections (e.g. gonorrhea, trichomonas vaginalis) or suffered an HIV/ hepatitis B virus (HBV)-infection will be excluded.
References
Publications (4)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDTeame H, Addissie A, Ayele W, Hirpa S, Gebremariam A, Gebreheat G, Jemal A. Factors associated with cervical precancerous lesions among women screened for cervical cancer in Addis Ababa, Ethiopia: A case control study. PLoS One. 2018 Jan 19;13(1):e0191506. doi: 10.1371/journal.pone.0191506. eCollection 2018. PMID 29352278
- BACKGROUNDAoki ES, Yin R, Li K, Bhatla N, Singhal S, Ocviyanti D, Saika K, Suh M, Kim M, Termrungruanglert W. National screening programs for cervical cancer in Asian countries. J Gynecol Oncol. 2020 May;31(3):e55. doi: 10.3802/jgo.2020.31.e55. Epub 2020 Feb 26. PMID 32266804
- BACKGROUNDWang B, He M, Chao A, Engelgau MM, Saraiya M, Wang L, Wang L. Cervical Cancer Screening Among Adult Women in China, 2010. Oncologist. 2015 Jun;20(6):627-34. doi: 10.1634/theoncologist.2014-0303. Epub 2015 May 8. PMID 25956407