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| Name | Class |
|---|---|
| Vancouver Prostate Centre | OTHER |
| Lady Davis Institute | OTHER |
| Bladder Cancer Canada | UNKNOWN |
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A new drug, erdafitinib, became available for some patients with bladder cancer that has spread to other organs. To qualify, patients must have specific genetic changes in their tumors. Currently, doctors use tumor tissue samples to check for these genetic changes, but these samples might not accurately reflect the current state of the patient's cancer.
In this study, Investigators will test the patient's blood for these genetic changes in addition to the tumor tissue samples. It is thought that the blood test will give a more accurate result.
Investigators hope this study will help to find out if more patients can benefit from erdafitinib than the ones identified by tissue testing only.
Recently, the first targeted therapy for patients with metastatic urothelial cancer (mUC) received approval, i.e. erdafitinib. Erdafitinib is a pan-FGFR small molecule inhibitor. Approximately twenty percent of mUC patients' tumors harbor qualifying alterations in FGFR2 or FGFR3. Currently, standard testing uses archival tumor tissue. However, this type of testing may not be representative of a patient's clinically dominant tumor clone at the time of treatment initiation due to temporal and spatial biopsy bias of archival tissue testing.
In this study, patients will undergo circulating tumor DNA testing, in addition to conventional tissue testing, for treatment eligibility. Investigators hypothesize that blood-based ctDNA testing will provide a more accurate assessment of somatic FGFR status than same patient archival primary tissue.
This study's objectives are:
Objective 1 (Primary): To evaluate the diagnostic value of ctDNA testing against the "gold standard" of tissue testing.
Objective 2 (Secondary): To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR alterations that are currently missed on tissue assays.
Procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Bladder Cancer | Patients with metastatic bladder cancer who will have archival tissue sent for FGFR testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FGFR Testing | Genetic | Determine whether ctDNA testing for FGFR provides the same results as the standard tissue testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the diagnostic value of ctDNA testing against standard tissue testing | Investigators will evaluate ctDNA as a diagnostic test against the de facto gold standard of tissue testing. | For the primary objective, a single blood sample is collected at the time of screening for treatment eligibility |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR mutations that are currently missed on tissue assays | To quantify the additional value of ctDNA testing, Investigators will calculate the percentage of eligible patients based on ctDNA testing among conventional testing ineligible or "negative" patients. | For this secondary objective, a single blood sample is collected at the time of screening for treatment eligibility |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic urothelial cancer who are screened for erdafitinib eligibility as standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard Eigl | British Columbia Cancer Agency | Study Chair |
| Alexander Wyatt | Vancouver Prostate Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur J.E Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada | ||
| Cross Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25533674 | Background | Knowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015 Jan;15(1):25-41. doi: 10.1038/nrc3817. | |
| 31340094 | Background | Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323. |
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No plans for future use of the data at this point. Only the study Principal Investigator will have access to the data in the future.
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Plasma ctDNA and archival tumour tissue will be tested for FGFR status.
| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| CHU de Québec-Université Laval | Québec | Quebec | G1R 2J6 | Canada |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |