| 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
|
|
|
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
|
|
|
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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