| CTRI Number |
CTRI/2023/03/050492 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Presence of Human Papilloma virus and changes in the cervix in immunocompromised women in coastal Karnataka |
|
Scientific Title of Study
|
prevalence of Human Papilloma virus and associated cytological abnormalities in immunocompromised at a tertiary level setting in coastal Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Pai |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Kasturba medical college, department of obstetrics and gynaecology, Manipal,
Udupi
KARNATAKA
576104
India |
| Phone |
9963598509 |
| Fax |
|
| Email |
poojanaravi2607@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba Medical College |
| Address |
Kasturba Medical College, Department of obstetrics and gynaecology, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba Medical College |
| Address |
Kasturba Medical college, Department of Obstetrics and Gynaecology, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| university grant, Kasturba medical college, Manipal |
|
|
Primary Sponsor
|
| Name |
university grant |
| Address |
kasturba hospital manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Pai |
Kasturba Medical College |
kasturba medical college, Department of Obstetrics and gynaecology, manipal 576104
Udupi
KARNATAKA |
9963598509
poojanaravi2607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (3) ICD-10 Condition: D848||Other specified immunodeficiencies, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women on immunosuppressant therapy, including long term steroids (≥6 months)
Those with confirmed retro-positive status
Women with chronic kidney disease
|
|
| ExclusionCriteria |
| Details |
Patients who underwent hysterectomy
Virgin women
Pregnant and postpartum upto 6 weeks
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
HPV test reports (HPV 16/18/other high risk Positive/ negative
Cytologic report- negative/ ASCUS/ ASC-H/ LSIL/HSIL/Invasive carcinoma
|
time bound |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For objective 2, Above variables will be compared with the CD4 count, viral load, adherence to HAART among retropositive women |
time bound |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
10/03/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary
objective:
The
prevalence of cervicovaginal Human Papilloma virus and cytological
abnormalities of the cervix in immunocompromised women at a tertiary level
setting in coastal Karnataka
Secondary
objective:
To
compare the HPV positivity/ cytological abnormalities against viral load, CD4
count, adherence to HAART among retropositive women |