| 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
|
|
|
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
|
|
|
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. | |