| CTRI Number |
CTRI/2017/12/010792 [Registered on: 06/12/2017] Trial Registered Prospectively |
| Last Modified On: |
05/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
New Cervical Cancer Screening Tool |
|
Scientific Title of Study
|
Validation Of A Panel Of Methylated Genes for Screening Of Cervical
Cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshita Naidu |
| Designation |
Junior Resident |
| Affiliation |
Kastuba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba Hospital, Manipal,
Udupi District, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9673329960 |
| Fax |
|
| Email |
naiduharshita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeksha Pandey |
| Designation |
Associate Professor |
| Affiliation |
Kastuba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba Hospital, Manipal,
Udupi District, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9241216016 |
| Fax |
|
| Email |
deekshiiiobg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshita Naidu |
| Designation |
Junior Resident |
| Affiliation |
Kastuba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba Hospital, Manipal,
Udupi District, Karnataka.
KARNATAKA
576104
India |
| Phone |
9673329960 |
| Fax |
|
| Email |
naiduharshita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Govt of India |
|
|
Primary Sponsor
|
| Name |
KH KMC Manipal |
| Address |
Kasturba Medical College,
Madhav Nagar,
Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Harshita Naidu |
Kasturba Hospital |
Department Of Obstetrics and Gynaecology.
Udupi
KARNATAKA |
9673329960
naiduharshita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, KH Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical Dysplasia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1)All patients diagnosed with LSIL, HSIL and Cancer cervix based on PAP smear or biopsy will be included as cases.
2)Women who are attending Kasturba Hospital,
Manipal gynaecology OPD with benign pathologies of genital tract with normal cervix on speculum
will be included as controls. |
|
| ExclusionCriteria |
| Details |
1)Not willing to participate in study.
2)Patient on immunosuppressive therapy.
3)Patients with more than one cancers.
4)Previously treated for any other cancers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: To see whether data obtained in tissue samples
can be translated in cytology samples, to be used as effective screening tool. |
at the end of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome measure: Comparison of methylation status of
various panel of genes in normal, pre-malignant and malignant lesions of cancer cervix. |
At the end of 2 years |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
01/01/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical cancer is still a major cause of mortality in women in developing countries. PAP smear which has been successfully implemented to reduce incidence of cancer in developed world has not been effective in the same way in developing world important reason being no national policy for screening coupled with low sensitivity of a single pap smear. Thus, there is a need to develop an objective screening tool which is very sensitive, specific and reproducible. This study is an extension of our earlier work where we proved epigenetic alterations in a panel of 11 genes was very helpful to detect cervical lesions. In this study, we are trying to exploit same results in cytological samples to use it as invasive tool. |