Clinical testing of the smartphone based device for early cervical cancer diagnosis

Recruiting

• Conditions: Patients who dont have signs and symptoms of Cervical cancer; Papillomavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2022/02/040066
• Lead Sponsor: PhotoSpIMeDx Private Limited

Brief Summary

Cervical cancer is one of the leading causes of deaths for women in India with an estimated 97,000 new cases and 60,000 deaths reported according to a report released by WHO in 2018. For cancers, early diagnosis is critical as it offers the patient an opportunity for successful curative treatment. In India, the crux of the problem lies in the lack of quality diagnostics, which could be affordable to all sectors of society and accessible to the remotest part of the country. Conventional techniques for cervical cancer detection are time-consuming, expensive, invasive by nature, limited by specificity and sensitivity and require experienced professionals for their operation. Among them histopathology with biopsy is the gold standard. Optical techniques, on the other hand, offer minimally invasive, fast and real time analysis criteria for diagnosis. This study focuses on the early detection of cervical cancer on the basis of spectroscopic differences present in different grades, CINI, CINII and CINIII, in their intrinsic fluorescence response. The device for cervical precancer diagnosis has been upgraded to a smartphone-based platform. Measurements will be done on patients with cervical pre-cancers of various grades. The selection will be done by the pathologist and gynaecologist involved in the project. The data recorded from the patient will be stored in the cloud storage  and it will be used to analyze the data for classifying the grades of the cancer. The examined patient’s pap smear and colposcopy reports will also be compared for classification purpose.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-05-08
• Study Start: 2022-07-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Women patients who visit the OPD and have symptoms or not of cervical cancer.

Exclusion Criteria

No criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome of study is the fluorescence signal captured from the patients that provide the biochemical changes happening inside the tissues during cancer progression. The fluorescence signal captures the changes of certain biomarkers which are present intrinsically such as FAD, Porphyrin, NADH etc. There concentration changes as as the cancer progresses inside the human.	The outcome of the study will be assessed after every 4 weeks from the date of trials start.

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (1)

GSVM MEDICAL COLLEGE; 🇮🇳 Nagar, UTTAR PRADESH, India

GSVM MEDICAL COLLEGE

🇮🇳Nagar, UTTAR PRADESH, India

Dr Kiran Pandey

Principal investigator

9415050322

dr.kiranpandey@gmail.com