跳至主要内容
临床试验/CTRI/2017/07/009005
CTRI/2017/07/009005尚未招募不适用

GynaeCam - Inspection Device For Cervical Cancer Screening - A pilot study at Chennai.

IIT Bombay1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年7月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
IIT Bombay
入组人数
600
试验地点
1
主要终点
Concordance between Gyneacam and Pap smear results.

研究概览

简要总结

Cervical cancer screening aids in detecting cancer prior to symptom manifestation in high risk women. It is carried out to identify and treat the cancer at the pre-cancerous stages eventually reducing the incidence and mortality of cervical cancer1 . Of the many screening procedures, cytology (Pap smear) is most commonly used. However, it is not feasible to perform cytology tests in remote locations in developing countries due to lack of infrastructure and trained manpower. The alternative procedures that could be employed in low resource settings are naked eye inspection after application of 3 – 5 % acetic acid (VIA), VIA using magnification devices (VIAM) and visual inspection after the application of Lugol’s iodine (VILI).  VIA test is a suitable alternative to Pap smear, but it has higher sensitivity and lower specificity than Pap smear2,5 resulting in unnecessary treatment and diagnostic procedures. The problem of lower specificity in VIA is addressed by the use of a colposcope. This additional step made the procedure expensive, time consuming and warranted the need for Gynaecologist. As an alternative, magnifying devices to aid VIA procedure were developed specifically for low resource settings. The use of Magnivisualizer is proposed as a triage to select women or dispense with colposcopy entirely6,7. Studies with the comparative performance of Magnivisualizer for VIAM and colposcope have found that it can be safely and accurately used in place of colposcopy without loss of efficacy of screening where colposcopy is not available for early diagnosis of precancerous and cancerous lesions of the cervix .

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 59.00 Year(s)(—)
性别
Female

入选标准

  • Women with an intact uterus, ever married, Women patients who visit the hospital for PAP Smear will also be enrolled, with prior consent.

排除标准

  • Women who are pregnant /undergone hysterectomy/ treated for pre-cancers or cancers in the past / menstruating will be excluded from the study.

结局指标

主要结局

Concordance between Gyneacam and Pap smear results.

时间窗: 1 Year

次要结局

  • Quality of images(1 year)

研究者

发起方
IIT Bombay
申办方类型
Other [Internal Grant]

研究点 (1)

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