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CTRI Number  CTRI/2024/09/073568 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Validity of KELIM score as a predictor of treatment outcome in patients diagnosed with advanced high grade serous ovarian cancer undergoing neoadjuvant chemotherapy and interval debulking surgery  
Scientific Title of Study   Validity of KELIM score as a predictor of treatment outcome in patients diagnosed with advanced high grade serous ovarian cancer undergoing neoadjuvant chemotherapy and interval debulking surgery  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anik Ghosh  
Designation  Consultant  
Affiliation  Tata Medical center, Kolkata 
Address  Tata Medical center 14, MAR (EW), New Town, Rajarhat, Kolkata 700160

Kolkata
WEST BENGAL
700160
India 
Phone    
Fax    
Email  anik.ghosh@tmckolkata.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepti S B  
Designation  DrNB Resident  
Affiliation  Tata Medical center , Kolkata 
Address  Tata Medical center 14, MAR (EW), New Town, Rajarhat, Kolkata 700160

Kolkata
WEST BENGAL
700160
India 
Phone  919611145292  
Fax    
Email  deepti.sb@tmckolkata.com  
 
Details of Contact Person
Public Query
 
Name  Deepti S B  
Designation  DrNB Resident  
Affiliation  Tata Medical center , Kolkata 
Address  Tata Medical center 14, MAR (EW), New Town, Rajarhat, Kolkata 700160

Kolkata
WEST BENGAL
700160
India 
Phone  919611145292  
Fax    
Email  deepti.sb@tmckolkata.com  
 
Source of Monetary or Material Support  
Not applicable  
 
Primary Sponsor  
Name  not applicable  
Address  not applicable  
Type of Sponsor  Other [not applicable ] 
 
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 
Deepti S B  Tata Medical Center   Tata Medical Center 14, MAR (EW), New Town, Rajarhat, Kolkata 700160
Kolkata
WEST BENGAL 
919611145292

deepti.sb@tmckolkata.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata medical center - Institutional Review Board  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  Histological Diagnosis: High Grade Serous Carcinoma (Ovary/Fallopian Tube/Peritoneum, HGSOC)

FIGO Stage(2014): Stage III and Stage IV (including sub-stages)

Will undergo the complete treatment regimen of neoadjuvant chemotherapy followed by interval debulking surgery and completion of remaining chemotherapy at TMCK
 
 
ExclusionCriteria 
Details  - Histological subtype other than HGSOC

- Recurrent HGSOC

- Unable to receive the complete treatment regimen due to any reason
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To calculate the correlation of KELIM score with histopathological chemotherapy response score (CRS), the surrogate marker of treatment outcome  16 months 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate the correlation of KELIM score with
- Surgical complexity score (SCS),
- Completeness of cytoreduction score (CC) and
- Progression free survival (PFS).
 
6 months 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   16/09/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

This research is proposed to prospectively assess if KELIM score can accurately predict treatment outcomes, in patients with advanced HGSOC receiving NACT. 

All newly diagnosed patients with HGSOC and FIGO Stage III or IV deemed to be inappropriate for primary debulking surgery by the multidisciplinary team and fit to receive NACT will be recruited into the study. Serum CA-125 levels will be measured and recorded at various time points: a. at the time of diagnosis, b. before every NACT cycle, c. prior to IDS and d. during every follow up visit after treatment completion. In addition, various other parameters related to the study, including intra-operative details and post-operative histological details(eg: Chemotherapy Response Score(CRS) will be recorded. KELIM score will be calculated for these patients using the first three serum CA-125 values during the first 100 days from the start of neoadjuvant chemotherapy, using a mathematical algorithm available on the website: https://www.biomarker-kinetics.org/CA- 125-neo.

Patients will be grouped into two groups as per their KELIM Score(< 1 or ≥ 1) and the score will then be correlated with various parameters which are related to treatment outcome. After surgery, patients will complete the remaining chemotherapy and CA-125 will be recorded during follow up visits. Maintenance chemotherapy with targeted agents or PARP inhibitor drugs will be based on the treating team.

Standard-of-care protocol for patient follow up will be followed. Rise of serum CA-125 levels above 35U/mL, and/or new onset symptoms suggestive of disease recurrence will initiate imaging with contrast enhanced CT/MRI of the abdomen and/or CT thorax. Radiological confirmation of disease recurrence will be considered as indication of restarting treatment for recurrence.


 
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