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CTRI Number  CTRI/2024/02/062458 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   Self-sample collection for cervical cancer test 
Scientific Title of Study   Efficacy of self-collected, air-dried and saline rehydrated Pap smears using vaginal tampon. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Irene Cheruvathoor 
Designation  Scientific Assistant F 
Affiliation  Tata Memorial Centre 
Address  Department of Cytopathology, Annex Building, 5th Floor, Room No. AB-502, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9930259002  
Fax    
Email  ireneruben1102@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saleem Pathuthara 
Designation  Lab Manager 
Affiliation  Tata Memorial Centre 
Address  Department of Cytopathology, Annex Building, 5th Floor, Room No. AB-503, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869081087  
Fax    
Email  saleempathuthara@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saleem Pathuthara 
Designation  Lab Manager 
Affiliation  Tata Memorial Centre 
Address  Department of Cytopathology, Annex Building, 5th Floor, Room No. AB-503, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869081087  
Fax    
Email  saleempathuthara@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Irene Cheruvathoor 
Address  Department of Cytopathology, Annex Building, 5th Floor, Room No. AB-502, Tata Memorial Hospital, Parel, Mumbai 400012 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Saleem Pathuthara  Department of Cytopathology, Annex Building, 5th Floor, Room No. AB-503, Tata Memorial Hospital, Parel, Mumbai 400012 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharmila Pimple  Tata Memorial Hospital  Department of Preventive Oncology, Service Block, 3rd Floor, Room No. 311, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177000

pimplesharmila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TATA MEMORIAL CENTRE INSTITUTIONAL ETHICS COMMITTEE - I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sexually active females greater than 30 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Sexually active women 30 years and above 
 
ExclusionCriteria 
Details  Post menopausal women that is complete cessation of menses for one year 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Conclusive positive or negative detection of malignancy  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Same cytology reports are traceable to biopsy. 1 year follow up and biopsy correlation.  1 year 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a pilot study to be conducted prospectively. 25 split Pap smear samples will be studied. The study aims to compare routine Pap smears with self-collected Pap smears using vaginal tampon and check the feasibility and diagnostic yield in both. The women who do not wish to go to a hospital for Pap smear, may opt for this self-collected Pap smear method, which will improve the participation rate in the cervical screening program.

Thus we aim to evaluate the efficacy of self-collected, air-dried and saline re-hydrated Pap smears using vaginal tampons.

Eligibility:

Inclusion criteria: (For split sample) – Sexually active women > 30 years of age – Willing to do self-collection using a vaginal tampon – and willing to get a Pap smear collected at the Department of Preventive Oncology, TMH, followed by VIA-VILI, colposcopy examination and cervical biopsy (if required)

Exclusion criteria: – Post-menopausal women

After explaining the self-collection procedure and  taking the volunteer’s sign on the informed consent, the volunteer will be instructed to do self-collection of vaginal sample using tampon at the Department of Preventive Oncology, TMH and subsequently Pap smear will be collected followed by VIA/VILI, colposcopy examination and biopsy (if required).On receiving in the lab, the air-dried smears will be rehydrated with normal saline for 30 seconds, fixed in methanol and then submitted for routine Pap staining.

After Pap staining, both the smears will be evaluated separately (blinded study) for various parameters such as cellularity, even spreading of cells on the glass slides, staining quality, presence / absence of transformation zone components, air-drying artifacts, cytomorphology (cell border, nuclear chromatin and border), presence/absence of inflammatory cells/ bacilli / organisms etc. and cytology report will be documented for both.

 
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