Skip to content

Study to find out the best method of kidney functions,using mathemetical calculation to estimate GFR (glomerular filtration rate) in patients with ovarian cancer who are planned for chemotherapy.

Prospective study to evaluate which method of estimated GFR best predicts for measured GFR in patients with ovarian cancer undergoing carboplatin-based chemotherapy.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/033138
Enrollment
100
Registered
2021-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

Interventions

None listed

Sponsors

ICMR Financial assistance to MDMSDMMChMDS thesis June
Lead Sponsor
Tata Memorial Centre Intramural fund will be applied for
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Consenting patients of Age greater than equal to 18 years 2.Planned for Carboplatin based treatment for newly diagnosed Epithelial Ovarian Cancer 3.Histo-pathological /Cytology Diagnosis

Exclusion criteria

Exclusion criteria: 1.Contra indication for baseline DTPA Renogram 2.Known history of CKD 3.Documented Viral Hepatitis 4.Immuno-compromised 5.Second malignancy 6.Carboplatin Allergy 7.Previous Treatment with Platinum

Design outcomes

Primary

MeasureTime frame
Primary Outcome: 1. To assess the root mean square error of the estimated GFR by the 3 different methods ââ?¬â?? Cockroft Gault ââ?¬â?? CKD EPI (BSA adjusted) ââ?¬â?? MDRD 6 (BSA adjusted) Compared to the measured GFR using Tc99 DTPA (plasma sampling method). Timepoint: Baseline

Secondary

MeasureTime frame
Secondary Outcomes: 1. To estimate the proportion of patients with APE (absolute percentage error) greater than 20% by the 3 methods of eGFR. 2. In a subset of patients estimate the target AUC with the AUC achieved as measured by carboplatin pharmacokinetics 3. Toxicity Assessment: Hematological Toxicities: Thrombocytopenia, Anemia, Neutropenia , Febrile Neutropenia As per CTCAE ver 5.0 in first cycleTimepoint: Baseline and 1 month

Countries

India

Contacts

Public ContactDr Rahul Ravind

Tata Memorial Centre

archana_jaya_ghosh@yahoo.co.in09769997881

Outcome results

None listed

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