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Due to constraints of COVID19, we were unable to recruit on-site for this study.
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The purpose of this study is to observe whether PARP inhibitors have an effect on serum creatinine level, and whether this reflects a change in creatinine secretion or a true change in kidney function.
PARPi medications interact with transporters along the renal tubules involved in the secretion of creatinine and an increase in serum creatinine is often observed in patients treated with these agents; however, it is not known whether PARP inhibitors are associated with an actual change in the glomerular filtration rate, or if the observed elevations of serum creatinine are a result of a drug effect on creatinine secretion unrelated to changes in kidney function. The investigators therefore propose a prospective observational study to examine the incidence of elevation in serum creatinine from baseline levels in patients initiated on PARP inhibitors and compare the estimated glomerular filtration rate based on creatinine to that from alternative tests.
The primary purposes of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with solid tumors receiving PARPi | Kidney function will be assessed by serum creatinine, serum cystatin C, and urine creatinine clearance calculation for patients who opt-in to 24 hour urine collection. These laboratory measures will be completed by patients at the following time points:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney Function Test | Other | Cystatin-C measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in eGFR from Baseline to On-Treatment, 3-9 weeks after PARPi Initiation (Time Point B) | Change in eGFR from baselineto on-treatment by ≥20% as measured using either cystatin C or 24h urine collection | Study labs will be obtained within 3-9 weeks after PARPi is initiated |
| Measure | Description | Time Frame |
|---|---|---|
| Within 4 Weeks of Post-discontinuation of PARPi (Time Point C) for patients with clinically significant changes in eGFR based on serum creatinine, cystatin C, or 24 hour urinalysis at Timepoint B | The percentage of patients who experience a eGFR reduction of ≥30%, and/or | Post-treatment (within 4 weeks of PARP inhibitor discontinuation, only for those patients with clinically significant changes in GFR based on serum creatinine, cystatin C, or 24 hour urinalysis at Timepoint B |
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Inclusion Criteria:
Exclusion Criteria:
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All patients will be recruited from the medical and gynecologic oncology practices at the Abramson Cancer Center / University of Pennsylvania. Patients that are 18+ years or older with a solid organ cancer who are being initiated on PARP inhibitor therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Payal Shah, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Kidney function will be assessed by serum creatinine, serum cystatin C, and urine creatinine clearance calculation for patients who opt-in to 24 hour urine collection.
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |