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CTRI Number  CTRI/2024/12/077849 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A study comparing new and old methods (FIGO 2023 v/s FIGO 2009) for staging Endometrial Cancer and how these changes affects treatment and the role of molecular testing 
Scientific Title of Study   A Single-Center Observational Study Comparing 2023 FIGO Staging with 2009 FIGO Staging in Endometrial Cancer Patients: Implications for Treatment Planning and the Role of Molecular Testing 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAJKRISHNA B 
Designation  ASSOCIATE PROFESSOR 
Affiliation  AMALA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF RADIATION ONCOLOGY AMALA INSTITUTE OF MEDICAL SCIENCES

Thrissur
KERALA
680555
India 
Phone  919626947477  
Fax    
Email  rajkb111@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  RAJKRISHNA B 
Designation  ASSOCIATE PROFESSOR 
Affiliation  AMALA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF RADIATION ONCOLOGY AMALA INSTITUTE OF MEDICAL SCIENCES

Thrissur
KERALA
680555
India 
Phone  919626947477  
Fax    
Email  rajkb111@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  RAJKRISHNA B 
Designation  ASSOCIATE PROFESSOR 
Affiliation  AMALA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF RADIATION ONCOLOGY AMALA INSTITUTE OF MEDICAL SCIENCES

Thrissur
KERALA
680555
India 
Phone  919626947477  
Fax    
Email  rajkb111@yahoo.co.in  
 
Source of Monetary or Material Support  
Amala Institute of Medical Sciences, Amala nagar, Thrissur, Kerala, India, 680555 
 
Primary Sponsor
Modification(s)  
Name  DR RAJKRISHNA B 
Address  DEPARTMENT OF RADIATION ONCOLOGY AMALA INSTITUTE OF MEDICAL SCIENCES, AMALA NAGAR, THRISSUR, KERALA,INDIA - 680555 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Sherawat   All India Institute of Medical Sciences (AIIMS)  Department of Medical Oncology, All India Institute of Medical Sciences, Virbhadra Road, Rishikesh, Uttarakhand- 249 203, India.
Dehradun
UTTARANCHAL 		 9958474477

dramitsehrawat@gmail.com 
Dr Ashwin Oommen Philips  Amala Institute of Medical Sciences  Department of Medical Oncology, Amala Institute of Medical Sciences Amala Nagar Thrissur Kerala India - 680555
Thrissur
KERALA 		 9003635373

drashphilsmog@gmail.com 
Dr Rajkrishna B  Amala Institute of Medical Sciences  Department of Radiation Oncology, Amala Institute of Medical Sciences Amala Nagar Thrissur Kerala India - 680555
Thrissur
KERALA 		 9626947477

rajkb111@yahoo.co.in 
Dr Soumya Surath Panda   Institute of Medical Sciences & SUM Hospital  Department Medical Oncology, Institute of Medical Sciences and SUM Hospital, K8, Kalinga Nagar Bhubaneswar, Odisha, India, 751003
Khordha
ORISSA 		 8895370579

dr.ssp82@gmail.com 
Dr Veena P  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Department of Gynaecology,Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry- 605006, India
Pondicherry
PONDICHERRY 		 9442121238

veenaup_2001@yahoo.com 
Dr Praveen Shenoy  Malabar Cancer Centre  Department of Medical Oncology, Malabar cancer centre Moozhikkara (P.O), Thalassery, Kannur District,Kerala, India-670103
Kannur
KERALA 		 9790463281

vppraveen233@gmail.com 
Dr Krishna Kumar Rathnam   Meenakshi mission hospital and research center  Department of Medical Oncology Meenakshi mission hospital and research center, Lake Area, Melur road, Madurai - 625107, Tamil Nadu, India
Madurai
TAMIL NADU 		 9380417299

kkrathnam@gmail.com 
Dr Kanu Priya Bhatia  Mohandai Oswal Cancer hospital  Department of Medical Oncology,Mohandai Oswal Cancer hospital, Grand Trunk Rd, Byepass, Sherpur, Ludhiana, Punjab, India- 141009, India
Ludhiana
PUNJAB 		 6283163257

bhatiakanu13@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
IEC AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR  Approved 
IEC AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR  Approved 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES, JIPMER, PUDUCHERRY  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE, AIIMS RISHIKESH  Approved 
INSTITUTIONAL ETHICS COMMITTEE, IMS AND SUM HOSPITAL,BHUBANESWAR  Approved 
INSTITUTIONAL ETHICS COMMITTEE, MALABAR CANCER CENTRE, THALASSERY  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE, MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE, MADURAI  Approved 
INSTITUTIONAL ETHICS COMMITTEE, MOHANDAI OSWALCANCER HOSPITAL, LUDHIANA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C541||Malignant neoplasm of endometrium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Histologically confirmed non - metastatic endometrial cancer.
2. Patients staged using both the FIGO 2023 and FIGO 2009 systems.
3. Eastern Co-operative Oncology Group (ECOG) performance score 0-2.
4. Patients who consent to molecular testing. 
 
ExclusionCriteria 
Details  1.Patients who have received prior treatment for endometrial cancer.
2.Patients with incomplete clinical or pathological data
3.Uterine sarcoma
4.Prior pelvic radiotherapy, hormonal therapy or chemotherapy
5.Those unfit for chemotherapy and radiation therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the stage migration in patients with endometrial cancer staged with FIGO 2009 to FIGO 2023 staging system and the outcomes of patients staged with FIGO 2023 staging system.  After ethical clearance, 5 years (2 years for patient recruitment, 3 years follow up) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate how treatment plans differ based on the FIGO 2023 vs. FIGO 2009 staging
2.To incorporate molecular testing [e.g. MMRd (MSI IHC), POLE, p53] in staging and explore its potential impact on prognosis and treatment.
3. Health related quality of life
4. To evaluate the disease-free survival (DFS) and overall survival (OS) in patients staged with FIGO 2023 staging system 		 After ethical clearance, 5 years (2 years for patient recruitment, 3 years follow up) 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   17/12/2024 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Endometrial carcinoma is the 6th most common cancer among women(1). In non-metastatic endometrial carcinoma, primary treatment is surgery. Following surgery, based on histopathological features, staging is done using International Federation of Gynaecology and Obstetrics (FIGO) system. FIGO 2009 system was been used for staging and in 2023, FIGO updated their staging system in 2023, which incorporated both histopathological and molecular features(2).Using the new FIGO system, there is stage migration, which leads to upstaging of disease which were previously low risk. But there is a lot of confusion on how to manage and incorporate the current staging into clinical practise and there is very little real world evidence from India. This study aims to fulfil the feasibility of using the new FIGO staging along with the molecular classification and see how it affects the treatment plans of patients with non-metastatic carcinoma endometrium from tertiary cancer center in India

 

 
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