| 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
|
|
|
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
|
|
|
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
|
|
|
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. |