FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090058 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Treatment Response failure in Ovarian Cancer Patients 
Scientific Title of Study   Molecular Characterization of Chemoresistance markers in Ovarian Cancer and its impact on Clinical Outcomes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumya Patil 
Designation  PhD Research Scholar 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences
Paneer, Derelkatte, Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9665137704  
Fax    
Email  soumyapatil781@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Uday Venkat Mateti 
Designation  Associate Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences
Paneer, Derelkatte, Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9665137704  
Fax    
Email  udayvenkatmateti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumya Patil 
Designation  PhD Research Scholar 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences
Paneer, Derelkatte, Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9665137704  
Fax    
Email  soumyapatil781@gmail.com  
 
Source of Monetary or Material Support  
Nitte University  
 
Primary Sponsor  
Name  Nitte University 
Address  6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangaluru, Karnataka 575018 
Type of Sponsor  Research institution and hospital 
 
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 
Soumya  Justice KS Hegde Hospital   Department of Oncology, Justice KS Hegde Charitable Hospital and Central Research Laboratory (CRL) of KS Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Karnataka, India.
Dakshina Kannada
KARNATAKA 		 9665137704

soumyapatil781@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee, Nitte University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Newly diagnosed ovarian cancer patients above the age of 18 years
2. Ovarian cancer patients who will receive at least 3 cycles of platinum-based chemotherapy
 
 
ExclusionCriteria 
Details  1. Patients with metastatic tumors originating from other primary sites
2. Patients with treatment history of platinum-based chemotherapy
3. Pregnant ovarian cancer patients
4. Patients with cognitive impairments and history of psychiatric illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical Outcomes such as Overall Survival, Progression Free Survival, Chemoresistance and Treatment Response  Baseline, 9 Weeks (after 3rd Chemotherapy Cycle), 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   14/07/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [soumyapatil781@gmail.com].

  6. For how long will this data be available start date provided 07-07-2025 and end date provided 26-06-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Ovarian cancer remains a major contributor to gynecologic cancer-related mortality, primarily due to late-stage diagnosis and the development of chemoresistance. A significant proportion of cases are detected at advanced stages (Stage III – 41.9%, Stage IV – 29%), resulting in poor prognoses despite standard platinum-based chemotherapy regimens. Approximately 70% of patients eventually develop resistance, contributing to suboptimal responses and a five-year overall survival rate of 50.6%. This study aims to investigate the expression patterns of chemoresistance-associated molecular markers in ovarian cancer patients and to evaluate their correlation with clinical outcomes. Particular focus will be placed on the role of Yes-associated protein 1 (YAP1) and Actin-like protein 6A (ACTL6A), both of which are implicated in tumor progression and resistance mechanisms via pathways such as HIPPO-YAP. Expression levels of chemoresistance markers will be correlated with clinical outcomes such as overall survival, progression free survival, chemoresistance and treatment response. 
Close