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Ameliorated Pap Tests and Cervical Cancer Screening Participation

NCT06968871RecruitingNAINTERVENTIONAL

Summary

The Pap test plays a crucial role in the early detection of cervical cancer. A pilot single-center randomized controlled trial applied the peak-end concept and added a non-painful step at the end of Pap smear screening, aimed to reduce recalled pain. However, there is still no multicenter study investigating the effect of the modified Pap test on cervical cancer screening participation. The present project is the first multicenter randomized controlled trial to expand the current scope of the peak-end theory into Pap tests and cervical cancer screening participation by adding a non-painful step at the end of Pap smear screening. Our multidisciplinary team (NTUH Pap Study Group) aims to provide innovative, feasible, and low-cost strategies for cervical cancer screening participation.

Key Facts

Lead Sponsor

National Taiwan University Hospital

Enrollment

248

Start Date

2026-03-01

Completion Date

2030-12-31

Study Type

INTERVENTIONAL

Official Title

Effects of the Ameliorated Pap Test on Cervical Cancer Screening Participation: a Multicenter Randomized Controlled Trial

Interventions

Modified Pap test

Conditions

Cervical Cancer ScreeningCervical Cancer Screening Methods

Eligibility

Age Range

25 Years+

Sex

FEMALE

Inclusion Criteria:

* Women aged 25 or above

Exclusion Criteria:

* Ongoing menstruation
* Pregnancy
* Incapability of understanding the numeric pain scales
* Any active cancer at study entry (defined as cancer diagnosed or treated within the previous 6 months, recurrent, regionally advanced or metastatic cancer)
* Previous hysterectomy, pelvic surgery, or radiotherapy
* Active vaginal or uterus infection
* Analgesic use within 24 hours

Outcome Measures

Primary Outcomes

3-year cervical cancer screening participation

Defined as attending a Pap test at any clinic before the end of the 3rd subsequent year following study entry

Time frame: 3 years

Secondary Outcomes

1-year cervical cancer screening participation

Defined as attending a Pap test at any clinic before the end of the next year following study entry

Time frame: 1 year

5-minute recalled pain intensity on a 1-5 numeric scale and a 0-10 visual analog scale

Recalled pain intensity at 5 minutes after the Pap smear test with evaluation by a 1-5 numeric scale and a 0-10 visual analog scale.

Time frame: 5 minutes after receiving the Pap smear test

3-month recalled pain intensity on a 1-5 numeric scale and a 0-10 visual analog scale

Recalled pain intensity at 3 months after the Pap smear test with evaluation by a 1-5 numeric scale and a 0-10 visual analog scale. To minimize potential propaganda for cervical cancer screening participation, the investigators choose the 3-month interval rather than 6-month or 1-year intervals for long-term pain recollection after Pap tests.

Time frame: 3 months after receiving the Pap smear test

Real time pain during the Pap test using a 1-5 numeric scale

The participants will evaluate and record their pain every five seconds throughout the test with an application on a 1 to 5 numeric scale. The average pain, the maximal pain, and real-time pain at the beginning, first quarter, second quarter, third quarter, and the end of the regular course are compared between the two groups. The investigators will compare the average pain of each group's first and second half of the course's course. For participants receiving the modified Pap test, the investigators further compare the average pain, the maximal pain, and the last recorded real-time pain of the 15-second step with that of the regular course.

Time frame: Every five seconds throughout the Pap test, up to completion of Pap test

Locations

National Taiwan University Hospital Yunlin Branch, Douliu, Taiwan

National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan

National Taiwan University Hospital, Taipei, Taiwan

National Taiwan University Cancer Center, Taipei, Taiwan

National Taiwan University Hospital Beihu Branch, Taipei, Taiwan

Linked Papers

2020-12-28

Comparisons of Papanicolaou Utilization and Cervical Cancer Detection between Rural and Urban Women in Taiwan

Using the claims data of one million insured residents in Taiwan from 1996–2013, this study identified 12,126 women in an urban city (Taichung) and 7229 women in a rural county (Yunlin), aged 20 and above. We compared Papanicolaou (Pap) test uses and cervical cancer detection rates between urban and rural women. Results showed that the Pap screening rate was slightly higher in rural women than in urban women (86.1 vs. 81.3 percent). The cervical cancer incidence was much greater for women without Pap test than women with the test (35.8 vs. 9.00 per 1000 in rural women and 20.3 vs. 7.00 per 1000 in urban women). Nested case-control analysis showed that Pap test receivers had an adjusted odds ratio (OR) of 0.35 (95% CI = 0.25–0.51) to be diagnosed with cervical cancer as compared to those who did not receive the test. The rural women had an adjusted OR of 1.46 (95% CI = 1.03–2.06) to be diagnosed with cervical cancer as compared to urban women. In conclusion, women in rural area are at higher cancer risk than city women. Women who do not undergo Pap tests deserve timely intervention of Pap test to prevent the onset of cancer, particularly in rural women with low income.

Cervical pap smears and pandemics: The effect of COVID-19 on screening uptake & opportunities to improve

Background: The Coronavirus disease 2019 (COVID-19) pandemic has led to an unprecedented upheaval within global healthcare systems and resulted in the temporary pausing of the National Health Service (NHS) Scotland Cervical Screening Programme. With several months of backlogs in appointments, there has not only been a reduction in primary samples being taken for human papilloma virus (HPV) testing but there have also been fewer women referred to colposcopy for investigation and treatment of precancerous or cancerous changes as a result. Encouraging uptake for cervical screening was always a priority before the pandemic, but it is even more important now, considering that the fears and barriers to screening that women may have are now exacerbated by COVID-19. Objectives: This article explores the impact of the pandemic on the uptake of cervical screening within NHS Ayrshire & Arran and evaluates potential strategies to improve uptake now and in future such as self-sampling and telemedicine. Methods: This article presents evidence-based literature and local health board data relating to cervical screening during the pandemic. Results: Human papilloma virus self-sampling carried out by the woman in her home has been shown to improve uptake, especially in non-attenders, whilst maintaining a high sensitivity and, crucially, reducing the need for face-to-face contact. Increased education is key to overcoming barriers women have to screening and telemedicine can strengthen engagement with women during this time. Conclusion: There are lessons to be learned from the pandemic, and we must use this opportunity to improve cervical screening uptake for the future.

Linked Investigators

Hannah Masson

Shwn-Huey Shieh