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A study to avoid biopsy in children having a kidney tumour on one side who need chemotherapy before surgery

Exclusion of pre-treatment biopsy in children with unilateral renal tumours who undergo delayed surgery: A prospective study - EBRT study (Exclusion of Biopsy in Renal Tumours)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064051
Enrollment
60
Registered
2024-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C790- Secondary malignant neoplasm of kidney and renal pelvis

Interventions

None listed

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: All patients of ages 6 months-10 years with the diagnosis of unilateral renal tumours on clinical and radiological examination, undergoing delayed surgery (after neo-adjuvant chemotherapy) at the paediatric onco-surgical without a diagnostic biopsy after informed consent during study period.

Exclusion criteria

Exclusion criteria: 1. Patients with renal tumours which are either planned for operation upfront or are bi-lateral will be excluded from the study. Upfront nephrectomy was performed in the absence of one or more imaging based high risk features perinephric spread or adjacent organ infiltration, tumors crossing the midline, intravascular thrombus, and extensive adenopathy. 2. Renal tumours with atypical features: age more than 10 years, uncertain renal origin, atypical metastases: bones or CNS (both at any age).

Design outcomes

Primary

MeasureTime frame
Incidence of non-Wilms tumors histology in patients undergoing delayed nephrectomy (post neo-adjuvant chemotherapy) without diagnostic biopsy.Timepoint: To follow up till 6 months after surgery

Secondary

MeasureTime frame
1.The incidence of non-Wilms histology in the study group to the historical cohort who underwent diagnostic biopsy for unilateral renal tumors 2.The incidence of complications associated with Core Needle Biopsy in our historical cohort. Timepoint: To follow up till 6 months after surgery

Countries

India

Contacts

Public ContactDr Akriti Tulsian

Tata Memorial Hospital

sajidshafiques@hotmail.com9820045398

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026