Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-28 @ 6:39 PM
Study NCT ID:
NCT06261892
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-cervical cancer', 'cervical cancer', 'CIN', 'Sanitary pad', 'non-invasive detection method', 'HPV'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '30207593', 'type': 'BACKGROUND', 'citation': 'Bray 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': '29352278', 'type': 'BACKGROUND', 'citation': 'Teame 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': '32266804', 'type': 'BACKGROUND', 'citation': 'Aoki 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': '25956407', 'type': 'BACKGROUND', 'citation': 'Wang 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.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/health-topics/cervical-cancer', 'label': 'Cervical Cancer'}, {'url': 'https://www.cancer.net/cancer-types/cervical-cancer/statistics.', 'label': 'Cervical Cancer: Statistics'}, {'url': 'https://www.cancer.net/cancer-types/cervical-cancer/screening-and-prevention.', 'label': 'Cervical Cancer: Screening and Prevention. Doctor-Approved Patient Information from ASCO'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is\n\n1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.\n2. If HPV DNA is not a promising biomarker, other biomarkers will be explored.\n3. To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.\n\nThe main question it aims to answer is:\n\nTo validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancer\n\nParticipants will\n\n1. Join the briefing session of the study\n2. Sign the consent form and health questionnaire\n3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test\n4. Collect the urine sample\n\nIf 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', 'detailedDescription': "First stage of study: Female subjects within the age group will first attend an online research briefing session. After the online briefing session, the participant is provided an opportunity to join a private 1-to-1 consultation session, which enables the participant to be more familiar with the details of the research content, consent form, study procedures, and data confidentiality. If they have no further questions regarding the research content, consent form, etc. during the consultation session. They will sign the consent for participating in the study, they will fill in a questionnaire (attached) and clinic pap smear application form (attached). The questionnaire helps the research team to understand the subject's medical, gynaecological, and sexual histories; a unique identifier code will be given to each subject.\n\nSecond Stage of study: The research team will select the subjects based on the questionnaire answers. If the selected subjects have undergone pap test/ HPV test or coloscopy recently, within 3 months, they will submit the related medical record with the unique identifier number to us. If the selected subjects have not undergone pap test/ HPV test or coloscopy recently, within 3 months, they will be sponsored to Pap test or/and HPV genotyping or/and colposcopy at the designated hospitals or clinics. When their Pap test or/and HPV genotyping or/and colposcopy results are available, they or the designated hospitals/ clinics will send us the related medical reports with the unique identifier number.\n\nThird Stage of Study: The participants will be further selected according to the medical records submitted. If the participants were selected to enter the third stage of the study, the selected subjects will submit their urine sample to us with a unique identifier number given."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged between 18 to 65\n* Have menstruation\n* Had sex before\n* Can read and write Chinese/ English\n* Without taking any medication (Except nutritional supplements, traditional Chinese medicine, and health care products etc.)\n\nExclusion Criteria:\n\n• 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.'}, 'identificationModule': {'nctId': 'NCT06261892', 'briefTitle': 'Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine', 'organization': {'class': 'INDUSTRY', 'fullName': 'WomenX Biotech Limited'}, 'officialTitle': 'Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine', 'orgStudyIdInfo': {'id': '2023-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collect HPV DNA from urine', 'interventionNames': ['Diagnostic Test: Collect HPV DNA from urine']}], 'interventions': [{'name': 'Collect HPV DNA from urine', 'type': 'DIAGNOSTIC_TEST', 'description': 'Use a sample collector to collect urine', 'armGroupLabels': ['Collect HPV DNA from urine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Alan LIU, Master', 'role': 'CONTACT', 'email': 'alanliu@womenx.net', 'phone': '+852 64786939'}], 'facility': 'WomenX Biotech Limited', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WomenX Biotech Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hong Kong Science and Technology Parks Corporation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Founder, Principal Investigator, Director', 'investigatorFullName': 'Pui Wah Choi', 'investigatorAffiliation': 'WomenX Biotech Limited'}}}}