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CTRI Number  CTRI/2016/08/007138 [Registered on: 03/08/2016] Trial Registered Prospectively
Last Modified On: 02/08/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study of pattern in which spread of kidney cancer in lymph nodes will be studied 
Scientific Title of Study   Study of Pattern of Lymph Nodal Spread in Pediatric Renal Tumors 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sajid Qureshi 
Designation  Professor, Surgical Oncology-Pediatric Division 
Affiliation  Tata Memorial Hospital 
Address  Room no.80, Medical Oncology-Pediatric Hematooncology Division, Ground floor, Main Building, Dr. E. Borges Road, Parel. Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9820045398  
Fax    
Email  sajidshafiques@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sajid Qureshi 
Designation  Professor, Surgical Oncology-Pediatric Division 
Affiliation  Tata Memorial Hospital 
Address  Room no.80, Medical Oncology-Pediatric Hematooncology Division, Ground floor, Main Building, Dr. E. Borges Road, Parel. Mumbai.


MAHARASHTRA
400012
India 
Phone  9820045398  
Fax    
Email  sajidshafiques@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sajid Qureshi 
Designation  Professor, Surgical Oncology-Pediatric Division 
Affiliation  Tata Memorial Hospital 
Address  Room no.80, Medical Oncology-Pediatric Hematooncology Division, Ground floor, Main Building, Dr. E. Borges Road, Parel. Mumbai.


MAHARASHTRA
400012
India 
Phone  9820045398  
Fax    
Email  sajidshafiques@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. E. Borges Road, Mumbai. Parel. Pin-400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E. Borges Road, Parel. Mumbai. Pin: 400012 
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 
Dr Sajid Qureshi  Tata Memorial Hospital  Room no.80, Ground floor, Main Building, Dr.E. Borges Road. Parel
Mumbai
MAHARASHTRA 
9820045398

sajidshafiques@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-I, Tata Memorial Hospital, Mumbai. Parel. 400012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Child cancer patients with kidney tumors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  •All renal tumors <18 years of age at diagnosis
•Willing to give consent for the study
 
 
ExclusionCriteria 
Details  •Previously treated patients,
•Recurrent or residual disease; and
•Patients not willing for consent. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Study of pattern of lymph nodal spread in pediatric renal tumors  During routine lymph node biopsy 
 
Secondary Outcome  
Outcome  TimePoints 
•To correlate radiological and pathological feature in stage III (i/v/o positive lymph node) disease.
•To describe the incidence of lymph node metastasis in patients undergoing upfront surgery and surgery after neoadjuvant chemotherapy.
•To define the minimum number of lymph nodes required for detecting metastasis 
During routine abdominal lymph node biopsy 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   03/08/2016 
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   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Renal tumors and amongst them, Wilms tumor is the most common tumor in children with excellent outcomes. Multimodal approach towards the tumor is important, however, surgery in addition has critical role in staging and thus further management of these tumors. Lymph nodes sampling is crucial in renal tumors since positive lymph nodes upstages the tumor with the resultant upgradation of intensity of treatment in the form of addition of doxorubicin and abdominal radiation. About 41% of stage III disease is identified on the basis of lymph nodes invasion alone. Intra-operatively, normal looking lymph nodes may harbor tumor deposits in 4-11% and in contrast enlarged lymph nodes may be negative in 40%.

Nodal assessment and sampling is based on surgeon’s discretion with the possibility of not removing sufficient numbers, removal of only enlarged nodes or not removing any lymph nodes. NWTS have reported sampling of minimum seven nodes for better assessment of the lymph node basin. The pattern of lymph nodes metastasis has not been studied in children with renal tumors and the significance or incidence of skip metastasis is not known. Moreover, there are no guidelines recommended for sampling of retroperitoneal lymph nodes. The assumption of sampling only the renal hilar lymph nodes as they are the first echelon lymph nodes is challenged in adults with renal cell carcinoma since non-hilar nodes may be involved without metastasis in the hilar nodes.

Primary objectives

·        Study of pattern of lymph nodal spread in pediatric renal tumors.

Secondary objectives

·        To correlate radiological and pathological feature in stage III (i/v/o positive lymph node) disease.

·        To describe the incidence of lymph node metastasis in patients undergoing upfront surgery and surgery after neoadjuvant chemotherapy.

·        To define the minimum number of lymph nodes required for detecting metastasis

All patients with renal tumors will undergo conventional work-up including CECT of abdomen/pelvis and thorax. Patients enrolled in CMART (ongoing WT project no: 993) study will also be included. Eligible patient will either receive preoperative chemotherapy or operated upfront. Surgery will be performed using abdominal or thoracoabdominal approach and lymph node sampling will be performed from lymph node stations (described below) after resection of the primary tumor.

Lymph node stations (right =R, left =L)- See figure

1)    Right renal tumor

a.    Suprahilar paracaval

b.    Hilar paracaval

c.    Infrahilar paracaval

2)    Left renal tumor

a.    Suprahilar pararotic

b.    Hilar pararotic

c.    Infrahilar pararotic

3)    In all

a.    Interaortocaval suprahilar

b.    Interaortocaval infrahilar

For right sided tumor – to remove A,B,C,D and E

For left sided tumor – to remove D,E,F,G and H.

The tumor specimen and lymph nodes will be appropriately labeled and sent for histopathological examination.

 The chemotherapy and radiotherapy will be as per the CMART study protocol.

Inclusion criteria

•      All renal tumors <18 years of age at diagnosis

•      Willing to give consent for the study

 

 

Exclusion criteria

·         Previously treated patients,

·         Recurrent or residual disease; and

·         Patients not willing for consent.

Lymph node sampling in childhood renal tumors is the standard of care, however there are no recommendations for lymph node sampling even in cooperative group studies. A systematic sampling of defined Lymph node stations will help us to the know the pattern of lymphatic spread and will help to identify Lymph node which are more likely to have metastatic deposits.  This may help us to reduce sampling errors and provide opportunities to correctly stage the patients since Lymph node involvement is very imp in staging and the treatment of renal tumors.

 

 
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