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临床试验/CTRI/2024/02/062458
CTRI/2024/02/062458尚未招募不适用

Efficacy of self-collected, air-dried and saline rehydrated Pap smears using vaginal tampon.

Irene Cheruvathoor1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Conclusive positive or negative detection of malignancy

研究概览

简要总结

This is a pilot study to be conducted prospectively. 25 split Pap smear samples will be studied. The study aims to compare routine Pap smears with self-collected Pap smears using vaginal tampon and check the feasibility and diagnostic yield in both. The women who do not wish to go to a hospital for Pap smear, may opt for this self-collected Pap smear method, which will improve the participation rate in the cervical screening program.

Thus we aim to evaluate the efficacy of self-collected, air-dried and saline re-hydrated Pap smears using vaginal tampons.

Eligibility:

Inclusion criteria: (For split sample) – Sexually active women > 30 years of age – Willing to do self-collection using a vaginal tampon – and willing to get a Pap smear collected at the Department of Preventive Oncology, TMH, followed by VIA-VILI, colposcopy examination and cervical biopsy (if required)

Exclusion criteria: – Post-menopausal women

After explaining the self-collection procedure and  taking the volunteer’s sign on the informed consent, the volunteer will be instructed to do self-collection of vaginal sample using tampon at the Department of Preventive Oncology, TMH and subsequently Pap smear will be collected followed by VIA/VILI, colposcopy examination and biopsy (if required).On receiving in the lab, the air-dried smears will be rehydrated with normal saline for 30 seconds, fixed in methanol and then submitted for routine Pap staining.

After Pap staining, both the smears will be evaluated separately (blinded study) for various parameters such as cellularity, even spreading of cells on the glass slides, staining quality, presence / absence of transformation zone components, air-drying artifacts, cytomorphology (cell border, nuclear chromatin and border), presence/absence of inflammatory cells/ bacilli / organisms etc. and cytology report will be documented for both.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Sexually active women 30 years and above.

排除标准

  • Post menopausal women that is complete cessation of menses for one year.

结局指标

主要结局

Conclusive positive or negative detection of malignancy

时间窗: 1 year

次要结局

  • Same cytology reports are traceable to biopsy. 1 year follow up and biopsy correlation.(1 year)

研究者

发起方
Irene Cheruvathoor
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Irene Cheruvathoor

Tata Memorial Centre

研究点 (1)

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