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CTRI Number  CTRI/2022/02/040347 [Registered on: 16/02/2022] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   PARA-AORTIC LYMPH NODE INVOLVEMENT IN EPITHELIAL OVARIAN CANCER A PROSPECTIVE STUDY 
Scientific Title of Study   PARA AORTIC LYMPH NODAL MAPPING IN EPITHELIAL OVARIAN CANCER A PROSPECTIVE COHORT STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AVIJIT MONDAL 
Designation  SENIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of surgical oncology All India Institute of Medical Sciences Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  84201866183  
Fax    
Email  avimaithon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KS RAJKUMAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPT OF SURGICAL ONCOLOGY ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  9940155250  
Fax    
Email  drksrajkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  AVIJIT MONDAL 
Designation  SENIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Dept of Surgical Oncology All India Institute of Medical Sciences Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  84201866183  
Fax    
Email  avimaithon@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Virbhadra Road Shivaji Nagar, near Barrage, Rishikesh, Uttarakhand 249203 
Type of Sponsor  Government medical college 
 
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 
AVIJIT MONDAL  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH  Department of Surgical Oncology
Dehradun
UTTARANCHAL 		 8420186183

avimaithon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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  80.00 Year(s)
Gender  Female 
Details  1. Patients with epithelial ovarian cancers who undergo systematic retroperitoneal lymph node dissection as part of their cytoreductive surgery (Primary/Interval/Secondary) at AIIMS Rishikesh & AIIMS Jodhpur

2. Patients aged 18 to 80 years

3. Willing to participate in the study (written informed consent)
 
 
ExclusionCriteria 
Details  1.Previous retroperitoneal lymph node dissection/surgery for any reason

2.Non curative surgery

3.Incomplete/Inadequate retroperitoneal lymph node dissection (for any reason) as deemed by the operating surgeon

4.Concurrent second malignancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
para-aortic nodal involvement  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Radiological and Pathological correlation of para-aortic nodal metastases in ovarian cancer patients   at baseline 
To determine 30 day surgical morbidity  30 days 
To determine the quality of life outcomes using EORTC QLQ-C30 questionnaire  30 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   22/02/2022 
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="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 06-01-2022 and end date provided 27-12-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Goal of surgery in ovarian cancer is to optimally resect out all the disease sites within the intra-peritoneal cavity and lymphadenectomy is an integral part of it. Rate of lymph nodal metastasis has been seen to range from 20-40% in early ovarian cancers to upto 50-80% in advanced stages. National Comprehensive Cancer Network (NCCN) currently recommends para-aortic node dissection (PAND) up to the level of Inferior Mesenteric Artery (at least) or renal vessels (preferrable) along with bilateral pelvic node dissection in newly diagnosed EOC involving pelvis / upper abdomen with

However, para-aortic nodal dissection is associated with a high morbidity including increased operative time, blood loss, lymphocyst, lymphedema etc. Severity of complications related to lymphadenectomy will also depend on the level of nodal dissection. The extent and template of nodal dissection is not well defined in ovarian cancer, largely due to lack of dedicated audit of the involved nodal basins in these subsets of the patients.

Present study is intended to map out the pattern of the lymph nodes involved para-aortic region in ovarian cancer. Such study should help the surgical oncologist to decide the extent of the lymph node dissection in relation to stage of the disease and associated risk benefit ratio.  
 
 
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