Comparative performance evaluation of Artificial Intelligence (AI) based visualinspection test (AI_VIA) with Primary Health Worker administered VIA (PHW_VIA), HPVDNA test and cervical cytology to detect cervical pre-cancer lesions.
- Conditions
- screening of women aged 30 to 60 years for cervical cancer
- Registration Number
- CTRI/2019/12/022368
- Lead Sponsor
- Periwinkle Technologies Pvt Ltd
- Brief Summary
In this study, we aim to evaluate the feasibility and clinical performance of Artificial Intelligence (AI) based visual inspection test(AI\_VIA) of a trained Machine Learning Camera model to perform AI based VIA Test with that of the conventional VIA performed by trained Primary Health Care workers (PHW\_VIA), and other current evidence based primary screening tests of HPV DNA and conventional cytology.
The study will demonstrate the proof-of-principle of an “automated visual evaluation†algorithm applied to archived, digitized cervical images for detection of cervical pre cancer lesions.
**Objective** : Comparative evaluation of AI\_VIA, HW\_VIA, Cervical cytology, and HPV DNA [Hybrid Capture 2 (HC2) test] for detection of cervical intraepithelial neoplasia grades 2 and above (CIN2+). **Study Design**: Cross – Sectional Study. **Inclusion criteria:** 1. Sexually active women aged 30–60 years 2. Non Pregnant 3. No history of prior treatment for cancer of the cervix 4. No history of hysterectomy 5. Healthy enough to undergo pelvic examination i.e. not seriously ill with any debilitating condition **Exclusion criteria:** 1. Women with a known diagnosis of cancer, any other terminal diagnosis 2. Not willing to undergo cervical cancer screening **Sample Size:**Sample size for estimating sensitivity and specificity with the 95% confidence level, a total sample size of 600 (which includes 36 subjects with the disease: cervical intraepithelial neoplasia ) to test for non inferiority of the new device using a two-sided binomial test. The prevalence of the disease at 1.6 % **Duration of the study:** 12 months
The study participants will be recruited from hospital and community based screening programmes in and around Mumbai India. Trained Medical Social workers will explain the details and the purpose of the study to participants attending the screening clinic. Apparently healthy women in the age group of 30-60 yrs with an intact uterus and no past history of cervical neoplasia will become eligible to participate in the programme. If they are fulfilling the inclusion criteria given above, a written informed consent in the vernacular language (either Hindi or Marathi) will be obtained from the participant and a unique participant identification number will be assigned to the eligible women. They will be enrolled after explaining the study and obtaining written informed consent. All the participants will be interviewed with the help of validated closed ended structured questionnaire will be interviewed to record their basic socio- demographic, personal, medical, reproductive, family planning history. Information will be collected by personal interview and documented as per the details indicated in data collection sheet.
**Informed Consenting Process :** Medical social worker will explain the study to the eligible participants and invite them to participants in the trial. A written informed consent will be obtained through signature/thumbprint. All the participants who are invited to participate will be given a participant’s information sheet, explaining the study in detail in simple vernacular language. They will be given time to go through it and come back with queries if any. The participants who are willing to participate will then sign the written informed consent form. Left hand thumb impression will be obtained from participants who are not able to sign. Another literate person will be invited to witness the procedure of consent administration and will sign as an impartial witness. The informed consent will clearly describe the purpose, objectives and the process of the study, potential use of the data and how it will be disseminated. Participants will be made aware of their right to refuse to participate. They will be made to understand the confidentiality that will be maintained in the study. Sufficient time will be given to each participant to think upon thereafter. Any doubts that arise out of the information sheet will be completely allayed and no pressure or coercion will be used for their participation.
**Post Test Counseling :** At the end of all testing procedures post test counseling will be done by the Doctor and Medical Social Worker to explain the significance and the results of the testing procedures performed. The importance of follow up visit to understand the results of screening tests , colposcopy and/ or cervical biopsy will be explained to the women
**Treatment:** Women with High grade Cervical Intraepithelial Lesion (CIN2) and above lesion will be recommended to seek treatment with cryotherapy or LEEP (Loop Electrosurgical Excision Procedure) or by cold knife conization as per the established protocols for treatment of cervical pre cancers at the Tata Memorial Centre, Mumbai. Women with Invasive Cancers will be referred to further treatment at the Tata Memorial Centre.
**Confidentiality and privacy of the participant’s information**: The investigators will maintain the confidentiality of the participants in the research project. The names of the study participants will be kept separate from the data / information collected from them by assigning a number to identify research subjects on the questionnaire. The identifying information will be kept in a locked cabinet. The confidentiality and privacy of the participant’s responses would be maintained as per the norms of the Ethics committee. The investigators and personnel involved in the study would be responsible for this. The information collected will not be used by the investigator or other personnel for any purpose other than conducting the study.
**BENEFITS:** ï‚·Objective assessment feature will remove the subjectivity of the VIA test reporting performed by primary care workers and also the dependency on trained manpower at primary health centers for performing VIA. ï‚· Decrease the reliance on repeated training and Quality Control measures required for conventional VIA Training ï‚· AI\_VIA can offer Point of care Triage test in the absence of resources for confirmation of diagnosis such as Colposcopy / Biopsy
**Safety and risks to human subjects:** Not Applicable **CONFLICT OF INTEREST:** No conflict of interest in any form
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 600
1.Sexually active women aged 30–60 years 2.Non Pregnant 3.No history of prior treatment for cancer of the cervix 4.No history of hysterectomy 5.Healthy enough to undergo pelvic examination i.e. not seriously ill with any debilitating condition.
1.Women with a known diagnosis of cancer, any other terminal diagnosis 2.Not willing to undergo cervical cancer screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study will demonstrate the proof-of-principle of an “automated visual evaluation†algorithm applied to archived, digitized cervical images for detection of cervical pre cancer lesions 12 months
- Secondary Outcome Measures
Name Time Method 1. Assessment of PHW_VIA 2. Assessment of HPV_DNA test 3. Assessment of cervical cytology
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Sharmila PimplePrincipal investigator9223207939pimplesa@tmc.gov.in