| CTRI Number |
CTRI/2020/01/022862 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of blood tests for early detection and treatment monitoring of cervical cancer |
|
Scientific Title of Study
|
Genetic analysis and development of liquid biopsy tests for early detection and treatment monitoring 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 |
Rama Rao Damerla |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College-Manipal |
| Address |
Department of Medical Genetics
Central Research Lab
KMC Complex
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9989955566 |
| Fax |
|
| Email |
rama.damerla@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rama Rao Damerla |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College-Manipal |
| Address |
Department of Medical Genetics
Central Research Lab
KMC Complex
Manipal
KARNATAKA
576104
India |
| Phone |
9989955566 |
| Fax |
|
| Email |
rama.damerla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rama Rao Damerla |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College-Manipal |
| Address |
Department of Medical Genetics
Central Research Lab
KMC Complex
Manipal
KARNATAKA
576104
India |
| Phone |
9989955566 |
| Fax |
|
| Email |
rama.damerla@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology |
|
|
Primary Sponsor
|
| Name |
DBT Ramalingaswamy Fellowship |
| Address |
Government of India
Ministry of Science and Technology
Department of Biotechnology
Block-2 7th Floor C.G.O Complex
Lodi Road New Delhi 110003 |
| 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 |
| Rama Rao Damerla |
Kasturba Hospital |
Dept of Medical Genetics, Central Research Laboratory, Kasturba Medical College and Hospital, Manipal Karnataka 576104
Udupi
KARNATAKA |
9989955566
rama.damerla@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria includes Patients 18 years old or older with suspicion of cervical cancer referred to Manipal Comprehensive Cancer Center. |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with inflammatory or haematological disease after the age of 18 will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The primary outcome is to measure the percentage of cervical cancers that can be detected using a liquid biopsy. Samples from follow up timepoints will be useful for analysis of treatment and their prognostic value for success of brachytherapy.
2. Measure recurrence in cervical cancer patients through serial monitoring with liquid biopsies (blood sample).
3. Identification of novel cervical cancer susceptible genes or genetic markers in the Indian population. |
0, 3, 6 months. Follow up at 36 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of novel cervical cancer susceptible genes or genetic markers in the Indian population. |
Pretreatment sample |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2020 |
| Date of Study Completion (India) |
27/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Study will be published Scopus indexed journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study aims to test if a digital PCR based assay for detection of HPV in circulating tumor DNA (ctDNA) is a sensitive and a sustainable tool for early detection of CIN2 and CIN3 cervical cancer. Treatment monitoring and detection of minimal residual disease in more invasive HPV associated cancers. |