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A clinical trial for early detection of cervical cancer using optical techniques

Phase 2
Completed
Conditions
Patients with suspected cervical cancer/ precancerous lesions
Registration Number
CTRI/2014/02/004424
Lead Sponsor
Centre for Earth Science Studies
Brief Summary

The study focuses on the noninvasive

detection of cervical pre-cancer/cancer  using a spectroscopic point monitoring andimaging systems and to develop an algorithm for grading the entire lesion basedon diffuse reflectance (DR) image ratios and cross validation by pointmonitoring of tissue fluorescence, reflectance and pathology.  Spectral variations in the cervix are studied using a fiber-optic pointmonitoring device and based on the recorded spectral variation biopsy will becollected from the measured cervical lesion for pathological correlation. DR image ratio and spectral data are analysed using multivariateanalytical methods and diagnostic accuracies will be calculated by comparingthe optical biopsy diagnosis with tissue biopsy (gold standard). As thesetechniques are comparatively low cost, reliable, non-invasive and real time, itwill have a significant impact on health care in the future.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
43
Inclusion Criteria

Patients with positive pap smear reports Patients referred for colposcopic examination Patients with any kind of clinically suspecting lesions in the uterine cervix.

Exclusion Criteria

Patient refusal Patients with transmittable diseases.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Identification of the malignant site for optimal biopsy and histology; and Reduction of false negativesFirst arrival at OP clinic
Secondary Outcome Measures
NameTimeMethod
Reduced trauma, morbidity; and Real-time, Noninvasive diagnosisAt the first visit to Clinic

Trial Locations

Locations (1)

Regional Cancer Centre

🇮🇳

Thiruvananthapuram, KERALA, India

Regional Cancer Centre
🇮🇳Thiruvananthapuram, KERALA, India
Dr Suchetha S
Principal investigator
4712522418
suchethajyothish@gmail.com

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