NCT01638637已完成不适用
Prospective Collection of Female First-catch Urine, Vaginal Swab, Cervical, and Endocervical Swab Specimens and Male Urethral Swab and First-catch Urine Specimens for Testing With the PANTHER® System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,492
- 试验地点
- 16
- 主要终点
- Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
研究概览
简要总结
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had intercourse within the past 12 months)
- •The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board (IRB)-approved waiver for parental consent for minors)
- •In addition, the subject must meet at least one of the following criteria:
- •The subject reports symptoms consistent with a suspected STI such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- •Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
- •Subject is asymptomatic and undergoing screening evaluation for possible STIs
- •Subject (female) is asymptomatic and undergoing a routine examination with a pelvic examination
排除标准
- •A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
- •The subject took antibiotic medications within the last 21 days
- •Subject already participated in this study
- •Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
- •Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
结局指标
主要结局
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
时间窗: approximately one year
次要结局
未报告次要终点
研究者
研究点 (16)
Loading locations...
相似试验
终止
不适用
Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) AssaysChlamydia InfectionsGonorrheaTrichomonas InfectionsNCT01728103Gen-Probe, Incorporated1,336
已完成
不适用
Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay TestingTrichomonas VaginalisNCT01427023Gen-Probe, Incorporated532
招募中
不适用
Vaginal Fluid Collection for Detection of Endometrial CancerEndometrial CancerNCT06294886Innovis LLC40
已完成
不适用
Tissue Samples and Bodily Fluid Specimens BankingEndocrine Disorders of Female Reproductive SystemNCT02431884University of Tennessee200
已完成
不适用
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)Human Papilloma Virus InfectionNCT02714114Universiteit Antwerpen57