| CTRI Number |
CTRI/2022/06/043540 [Registered on: 28/06/2022] Trial Registered Prospectively |
| Last Modified On: |
13/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of cervical cancer microbiome during cervical cancer progression |
|
Scientific Title of Study
|
Influence of microbiome and mechanism during cervical cancer progression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Satyamoorthy |
| Designation |
Professor and Director |
| Affiliation |
Manipal School of Life Sciences |
| Address |
Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845718604 |
| Fax |
|
| Email |
ksatyamoorthy@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Satyamoorthy |
| Designation |
Professor and Director |
| Affiliation |
Manipal School of Life Sciences |
| Address |
Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9845718604 |
| Fax |
|
| Email |
ksatyamoorthy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Satyamoorthy |
| Designation |
Professor and Director |
| Affiliation |
Manipal School of Life Sciences |
| Address |
Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9845718604 |
| Fax |
|
| Email |
ksatyamoorthy@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Science for Equity Empowerment and Development |
| Address |
Department of Science & Technology, Government of India |
| Type of Sponsor |
Government funding agency |
|
|
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 K Satyamoorthy |
Kasturba Hospital |
Department of Obstetrics & Gynaecology, Manipal, Karnataka, room number 13.
Udupi
KARNATAKA |
9845718604
ksatyamoorthy@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospotal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No treatment |
Not applicable |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women within the age group of 21-65 years with or without pre-malignant
2. malignant cervical lesions will be included in the study |
|
| ExclusionCriteria |
| Details |
1. Women who are pregnant and /or lactating at the time of the study, women who have undergone hysterectomy adenocarcinoma of the cervix
2. Women who have been diagnosed and have already started treatment for cervical lesions and malignancies will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study aims at the identification, characterization, and elucidation of relevant pathways and targets responsible for tumor progression cervical cancer upon HPV infection in relation to the co-inhabiting microbiome. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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)
|
01/07/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The main objective of the study is to identify bacterial biomarkers, elucidate pathways that are responsible for tumor progression, and target the identified biological markers (pathways/proteins) by treating with specific sets of chemotherapeutic agents. |