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Circulating tumor DNA in urothelial cancer.


- candidate number18312
- NTR NumberNTR4681
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2014
- Secondary IDsN13KCM NKI-AVL
- Public TitleCirculating tumor DNA in urothelial cancer.
- Scientific TitleLongitudinal kinetics of cancer mutations in the plasma, urine and tumor of patients with urothelial cancer treated with chemotherapy
- ACRONYM
- hypothesisTo dermine the kinetics and spectrum of tumor mutations in the urine and plasma of bladder cancer patients receiving neoadjuvant chemotherapy for locally advanced cancer or systemic therapy for metastatic disease.
- Healt Condition(s) or Problem(s) studiedBladder carinoma
- Inclusion criteria- Indication for systemic treatment with anti-cancer agents in patients with urothelial cancer.
- WHO performance status 0-2
- age > 18yr
- Written informed consent
- Exclusion criteria- Coleection of tissue from a metastatic or primary lesion is not possible.
- Pure non-urothelial carcinoma (SCC/Adenocarcinoma) of the bladder or urinary tract
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate1-jan-2018
- Target number of participants80
- Interventions- Peripheral blood samples
- Urine samples
- Tumor biopties
- Primary outcomeTo explore the longitudinal kinetics of tumor mutations in the urine and plasma of bladder cancer patients receicing systemic therapy fo locally advanced cancer or metastatic disease.
- Secondary outcome- To determine the detectability rate and range in levels ctDNA in plasma before start of treatment
- To explore the correlation of levels of ctDNA in plasma with tumor burden
- To explore the correlation between radiological response and urine ctDNA and plasma ctDNA kinetics during and following treatment
- To explore the prognostic value of urine ctDNA and plasma ctDNA for treatment outcome (progression free survival) of neoadjuvant chemotherapy for bladder cancer
- To explore the range and frequency of mutations found in ctDNA, urine ctDNA and tumor samples in bladder cancer.
- Build a biobank of longitudinally collected bladder cancer samples for translational research.
- TimepointsRadiological evaluation: patients will be evaluated according to local clinical practice:
During neoadjuvant treatment:
- Initial clinical staging: physical exam, TUR or bladder biopsy, FDG-PET CT thorax/abdomen/pelvis.
-After 2 cycles to determine tumor response:
Physical exam, cystoscopy and CT thorax/abdomen/pelvis-scan
-After 4 cycles (CT/FDG-PET)
-6 and 12 months after cystectomy
For metastatic disease: after 3 cycles of therapy by CT-scan.
Response evaluation will be assessed according to RECIST version 1.1 guidelines.25
Clinical evaluation: patients will be seen according to standard of care:
During neoadjuvant treatment before each cycle of chemotherapy to assess treatment toxicity and response to treatment. After cystectomy every 3 months in the first year and every 6 months in the second year to assess disease control. If clinically indicated, further radiological or metabolic response evaluation will be done.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD M.S. Heijden, van der
- CONTACT for SCIENTIFIC QUERIESMD PhD M.S. Heijden, van der
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- Publications
- Brief summaryStudy design:
Plasma, urine and tumor specimens will be prospectively collected to determine the longitudinal kinetics of cancer mutations in bladder cancer during chemotherapy and at relapse. In addition, material collected in this study will be used to optimize the analysis of ctDNA in our institute and to establish this technique at the NKI/AVL.

Study population:
The target population consists of patients who have suspected or confirmed urothelial cell cancer of the bladder or urinary tract and who will be treated with systemic therapy. In addition, a small number of patients with non-muscle invasive cancer will be included as controls.

Main study parameters/endpoints:
Primary endpoint:
-The longitudinal kinetics of the spectrum of tumor mutations in the urine and plasma of bladder cancer patients receiving systemic therapy.
-To explore the predictive value of changes in urine cfDNA and plasma ctDNA for treatment outcome (progression free survival and pathological response rate) of neoadjuvant chemotherapy for bladder cancer
- Main changes (audit trail)
- RECORD8-jul-2014 - 10-aug-2014


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