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A Comparative Study Of Truscreen vs Pap Smear For Cervical Cancer Screening In General Screening Populatio

Phase 3
Completed
Registration Number
CTRI/2020/01/022650
Lead Sponsor
Khandelwal laboratories Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
645
Inclusion Criteria

1. Able to understand the conditions of the trial.

2. Willing and able to sign the patient information sheet and consent form.

Exclusion Criteria

1. Under the age of 18 and over the age of 65 years

2.Recent ( <6 weeks) Pap Smear

3.Current menstrual period with heavy flow (days 1-3)

4.Known to be pregnant or less than 4 months post-delivery

5.Received surgical treatment to the cervix (including punch biopsies)

6.Previous hysterectomy (corpus and cervix)

7.Receiving experimental photodynamic therapy or otherwise exposed to photosensitive drugs, or suffering from a photosensitising disease (eg, porphyria, lupus erythematous)

8.Has received radiotherapy treatment in the pelvic region at any time previously

9.Receiving chemotherapy, or has received chemotherapy within the last 5 weeks

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Colposcopy and biopsy outcome <br/ ><br>oPatient Reported satisfaction rate as compared to PAP smear <br/ ><br> <br/ ><br>Timepoint: 3 months, 6 months, 9 months.
Secondary Outcome Measures
NameTimeMethod
Patient Reported satisfaction rate as compared to PAP smear <br/ ><br>Timepoint: 3 months, 6 months, 9 months.
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