Kidney/Urinary CancerNCT02108587
Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer
A study testing optical coherence tomography in people with Kidney/Urinary Cancer, run by Case Comprehensive Cancer Center.
Trial summary
This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney/Urinary Cancer
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have radiographic evidence of upper tract urothelial cancer by computed tomography (CT), magnetic resonance imaging (MRI) or intravenous pyelogram (IVP) in order to undergo this procedure
- Patient who will undergo standard of care clinical staging for UTUC
- Patient ability to read and comprehend the informed consent document
Who cannot join
- Patient who has a contraindication to endoscopy
- Patient who is pregnant
About this study
Official title: Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography
This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. It also helps the doctor plan the appropriate treatment. Optical coherence tomography is a procedure that uses infrared light waves to give three-dimensional pictures of structures inside tissues and organs. The pictures are made by a computer linked to the light source. Optical coherence tomography may be effective in staging patients with upper-tract urothelial carcinomas.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the feasibility and imaging ability of optical coherence tomography (OCT) to stage upper-tract urothelial carcinomas (UTUC).
OUTLINE:
Patients undergo optical coherence tomography over 10-15 minutes.
After completion of study, patients are followed up at 3 months.
- Conditions
- Kidney/Urinary Cancer
- Being tested
- optical coherence tomography
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
Undergo optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| optical coherence tomography for diagnosis | Experimental | Patients undergo optical coherence tomography over 10-15 minutes. Receives: Device: optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC)
Feasibility defined as the ability to relate the features associated with cancerous tissues in pathohistological analysis to the features in OCT images
Measured: Up to 3 months
Secondary outcomes (1)
Imaging Analysis
Number of cancerous images with at least one feature different from normal pathology slide
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney/Urinary CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Donald Bodner, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108587
- Sponsor's protocol ID
- CASE11811
- Other IDs
- NCI-2014-00347, CASE 11811, P30CA043703
- Status last verified
- Oct 2016
- First submitted
- 7 Apr 2014
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02108587
- Acronym / sponsor ID
- CASE11811
- Conditions
- Kidney/Urinary Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. It also helps the doctor plan the appropriate treatment. Optical coherence tomography is a procedure that uses infrared light waves to give three-dimensional pictures of structures inside tissues and organs. The pictures are made by a computer linked to the light source. Optical coherence tomography may be effective in staging patients with upper-tract urothelial carcinomas.
Detailed description
PRIMARY OBJECTIVES:
- To test the feasibility and imaging ability of optical coherence tomography (OCT) to stage upper-tract urothelial carcinomas (UTUC).
OUTLINE:
Patients undergo optical coherence tomography over 10-15 minutes.
After completion of study, patients are followed up at 3 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optical coherence tomography for diagnosis | Experimental | Device: optical coherence tomographyPatients undergo optical coherence tomography over 10-15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have radiographic evidence of upper tract urothelial cancer by computed tomography (CT), magnetic resonance imaging (MRI) or intravenous pyelogram (IVP) in order to undergo this procedure
- Patient who will undergo standard of care clinical staging for UTUC
- Patient ability to read and comprehend the informed consent document
Key exclusion criteria (2 listed)
- Patient who has a contraindication to endoscopy
- Patient who is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomographyUndergo optical coherence tomography | Device | optical coherence tomography for diagnosis |
Primary outcome
Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC)
Time frame: Up to 3 months
Feasibility defined as the ability to relate the features associated with cancerous tissues in pathohistological analysis to the features in OCT images
1 secondary outcome
Imaging Analysis
Time frame: Up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
Related trials for Kidney/Urinary Cancer
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Bodner, MD principal investigator
Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing optical coherence tomography in people with Kidney/Urinary Cancer, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.