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CTRI Number  CTRI/2024/12/078588 [Registered on: 26/12/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A Study of blood based MicroRNAs to Assess Response and Prognosis among Cervical Cancer Treated with Chemoradiotherapy 
Scientific Title of Study   A Prospective Study of Validation of MicroRNAs to Assess Response and Prognosis among Cervical Cancer Treated with Radical Image-guided Chemoradiotherapy- MARC Study 
Trial Acronym  MARC study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranav P V 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiation Oncology KMC Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  6371359736  
Fax    
Email  ppvshawn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shirley Lewis Salins 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiation Oncology KMC Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9969557231  
Fax    
Email  shirley.salins@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shirley Lewis Salins 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiation Oncology KMC Manipal Udupi Karnataka


KARNATAKA
576104
India 
Phone  9969557231  
Fax    
Email  shirley.salins@manipal.edu  
 
Source of Monetary or Material Support  
Contingency fund of co-investigator, Kasturba Medical College and School of life Sciences, Manipal Academy of Higher Education, Manipal, India 
 
Primary Sponsor  
Name  Shama Prasada Kabekodu 
Address  Professor and Head Department of Cell and Molecular Biology Manipal School of Life Sciences MAHE, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shirley Lewis Salins  Kasturba Medical College, Manipal  Department of Radiation Oncology Room number 01 Ground floor Shirdi Sai Cancer Block KMC, Manipal
Udupi
KARNATAKA 		 9969557231

shirley.salins@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  Patient undergoing curative image guided radiation with or without chemotherapy
Histologically confirmed diagnosis of cervical cancer
FIGO stages IB3- IVA 
 
ExclusionCriteria 
Details  Patients undergoing surgery as the definitive treatment

Synchronous carcinomas

Metastatic at presentation

Poor PS ECOG 3-4

Palliative intent of treatment

Prior history of surgery/radiotherapy/chemotherapy to pelvis

Neuroendocrine carcinoma of cervix 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the miRNA level in blood with clinical-radiological response at three months post chemoradiation  3 months after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the miRNA level in blood with 2-year overall survival (OS) and disease-free survival (DFS).

To correlate the miRNA level in blood with acute and late toxicities.

To assess the quality of life (QOL) of patients undergoing image-guided radiotherapy.

To establish patient-derived cell lines for in-vitro functional studies. 		 2 years post treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   06/01/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Cervical cancer is a major cause of mortality worldwide as well as in India. The standard treatment for locally advanced cervical cancer (LACC) patients consists of radiotherapy (45 Gray in 25 Fractions over 5 weeks) in combination with weekly cisplatin/carboplatin-based chemotherapy. Unfortunately, nearly 20-30% of patients with cervical cancer have an unfavourable response to conventional chemoradiation treatment; these patients have a higher recurrence rate and worse survival in the first five years. We need to identify certain biomarkers to predict the clinical response in cervical cancer patients receiving chemoradiation and correlate with prognosis. MicroRNAs(miRNAs) are potential biomarkers in cervical cancer; however, their role in identifying patients who do not respond to conventional treatment remains poorly investigated. This study is aimed to evaluate some potential miRNAs which have shown good correlation in invitro to be evaluated in clinical settings and correlate with response and prognosis.
40 patients with biopsy proven cervical cancer will be recruited for the study. Informed consent will be taken prior to enrollment in the study. Standard treatment of cervical cancer will be followed. Tissue biopsy/brush sampling will be obtained at baseline prior to treatment and at 3 months after chemoradiation. The blood samples will be collected at the following time points –
1. Diagnosis
2. Completion of EBRT
3. Completion of Brachytherapy
4. 3 months after the completion of treatment
5. 1 year after treatment
6. 2 years after treatment
7. At recurrence or metastases.
We plan to generate patient specific cell lines which will be used for validating the clinical endpoints. The tumor biopsies taken from the patients will be washed with phosphate buffered saline, will be incubated with antibiotic–antimycotic for 20 s, washed once in PBS, incubated in gentamicin for 20 s and then washed in PBS. The tissue will be cut into small pieces, treated enzymatically with collagenase for 1 hrs at 37 ºC and placed in a cell culture dish for 10 min to attach and cultured in the presence of Epithelial Cell Growth Medium containing 10% FBS. The cells will be harvested by trypsinization, and western blotting will be carried out for pan-cytokeratin, cytokeratin 8 and E-cadherin to confirm the cells. These cell lines will be used to validate the findings obtained patient data.
Response assessment and follow up schedule:
After completion of chemoradiation and brachytherapy, patient will be assessed at 1 month post radiation to assess response and toxicity. The response at 3 months will be assessed clinically and with MRI pelvis as per routine practice. The follow up schedule is 3 monthly till two years and then 6 monthly till 5 years. Thereafter patients are followed up yearly.
 
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