An observational study in CNS Lymphoma and CNS Involvement of Systemic Lymphoma, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-22.
Sponsored by Dana-Farber Cancer Institute · Observational
The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.
We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection.
Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 40 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
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Patients receiving high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital
Exclusion Criteria:
To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.
Serum creatinine-based equations to be included in that analysis are: Cockcroft-Gault with the following weight descriptors; ideal body weight, actual body weight, and adjusted body weight; Modified MDRD; CKD-EPI.
Time frame: 1 year
To further compare each formula in a different subset of patients.
To further compare each formula in a different subset of patients: Age \< 65 years and \>/= 65 years; body mass index \< 25, 25-30, 30-35, and \> 35; serum creatinine \<1.5 mg/dL and \>/= 1.5 mg/dL.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute