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CTRI Number  CTRI/2015/10/006324 [Registered on: 28/10/2015] Trial Registered Retrospectively
Last Modified On: 27/10/2015
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Single Arm Study 
Public Title of Study   Assessing accuracy of CT scan based staging for Wilms Tumor(Kidney Tumor) where we know Multislice CT scan is more advanced tool 
Scientific Title of Study   Diagnostic accuracy of CT based staging of Wilms’ tumor in the era of Multislice CT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1547  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Seema A Kembhavi 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr.Earnest Borges Marg
Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9867981284  
Fax  91-22-24146937  
Email  seema.medhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Garima Pathak 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr.Earnest Borges Marg
Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax  91-22-24146937  
Email  garimanmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seema A Kembhavi 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr.Earnest Borges Marg
Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9867981284  
Fax  91-22-24146937  
Email  seema.medhi@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr.Earnest Borges Marg Parel Mumbai 400012 
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 
Dr Seema Kembhavi  Tata Memorial Hospital  Dr. E. Borges Road. Behind Childrens Wadia Hospital Parel, Mumbai.
Mumbai (Suburban)
MAHARASHTRA 
9867981284
91-22-24146937
seema.medhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-I, TMH, Parel, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of Wilms tumor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1) Histopathological proof of WT
2) Images on PACS
3) Surgery done in TMC
4) Histopathology report available
 
 
ExclusionCriteria 
Details  1) Bilateral tumors
2) Non-wilms’ renal tumors 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sensitivity & Specificity of CT staging. In case of discordance between two observers, final stage assignment would be decided upon after discussion between two radiologists.
Positive and Negative predictive values of specific CT findings – features with high values will be highlighted.
Overall Diagnostic Accuracy will be assessed
An attempt will be made to identify clusters in cases with discordant findings will be calculated for inter-observer agreement.
 
At the end of the study
 
 
Secondary Outcome  
Outcome  TimePoints 
To asses for inter-observer agreement in predicting CT stage  At the end of the study 
 
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)   24/07/2015 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Wilms’ tumor (WT) is the most common pediatric renal tumor and the fifth most common childhood cancer. This tumor has good outcome, with current survival rate of 86-96%.

There are two approaches in treating these tumors: The SIOP (International Society of Paediatric Oncology) approach advocates a short course of chemotherapy prior to surgery, followed by stage appropriate chemotherapy with or without radiotherapy while the NWTS (National Wilms’ Tumor Study group) approach warrants upfront surgery resulting in accurate staging and appropriate therapy.

Both approaches have pros and cons. The advantage of SIOP approach is down-staging caused by pre-operative chemotherapy. However, patients treated with SIOP approach are often treated without a biopsy (within acceptable risk) and patients may receive a suboptimal chemotherapy for a non-WT or in rare cases, chemotherapy may be administered to benign tumors. The advantage of NWTS approach is accurate staging and stage based therapy. However, with NWTS approach, there is a higher incidence of stage III disease, commonly due to spillage, that warrants radiotherapy and increase in the chemotherapeutic regimen drugs and duration.

There is a potential to achieve a “win-win” situation if patients could be preselected for eitherapproach. The unilateral non-metastatic tumors which are intra-capsular / non-adherent to adjacent structures/ those who do not have extensive venous thrombosis can be safely resected out upfront, while those who have

locally advanced disease could benefit from pre-operative chemotherapy.

 

These features can be identified on imaging, however, CT has often been criticized in the past for poor accuracy. In the current era of multislice CT, there is a possibility that evaluation of local spread has become more reliable, thus improving the accuracy of CT imaging.

 

In this retrospective study, we want to evaluate the diagnostic accuracy of CT in staging of Wilms’ tumor.

 

If CT is found to be reliable, it may be successfully used in triage of patients in the future.The electronic data base will be searched for 50 consecutive WT cases having an in-house CT scan done within 15 days of surgery, intra-operative findingsand histopathological report. Patients with complete information will be included on the study and an electronic data base of CT findings, relevant intra-op findings and histopathology will be created.

 

Two radiologists (Dr. Seema A. Kembhavi and Dr. PalakPopat) who are blinded to surgical and histological findings will review the CT scans. Surgical notes and histopathology data will be retrieved from EMR by a third person (Dr. Garima).

 

Following information will be collected (CRF has details)

  • Age
  • Sex : male/female
  • Laterality: right/left
  • Extent of involvement in the kidney
  • Size of the mass
  • Renal vein thrombosis, if present, its extent into IVC
  • Renal sinus involvement
  • PC system involvement
  • Ureteric involvement
  • Any e/o capsular involvement or extra-capsular spread
  • Adenopathy
  • Spillage, ascites, peritoneal disease
  • Metastases
  • Contralateral kidney

 

CT stage will be assigned based on CT findings by each observer. In case of discordance, a final stage will be decided up on agreement. This information will be compared with Reference standard – surgical noted and histopathology.

 

For patients with stage IV disease, local stage of tumor will be assessed as I/II/III.

 

For the patients who have received pre-operative chemotherapy, the post chemotherapy scan will be evaluated. 

 
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