Upper Tract Urothelial Carcinoma Receiving Kidney-sparing TherapyNCT06204406
Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
An observational study of Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy, run by RenJi Hospital at 1 site in China.
Trial summary
Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
- What is being tested?
- Observational
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy
Who may be able to join
- Histopathological confirmed upper tract urothelial carcinoma;
- Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery;
- Participants must be willing to attend the follow-up visits;
- Sign informed consent.
Who cannot join
- Unable to undergo kidney-sparing surgery;
- Life expectancy < 6 months;
- Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 200123
Jiwei Huang, Dr, 8621-68383544, jiweihuang@outlook.com
About this study
Official title: A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is <50% for pT2/T3 and <10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.
Read the detailed description
The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.
- Being tested
- Observational
- Keywords
- kidney-sparing therapy, upper tract urothelial carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This is a prospective observational study with observation only and no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy | The enrolled patients were patients with limited-stage or locally advanced UTUC, who were classified into the following four categories according to the 2022 EAU guidelines as low-risk and high-risk: 1) low-risk patients who were willing to undergo kidney-sparing surgery directly; 2) High-risk patients, with solitary kidney, functional single kidney, bilateral tumors, and absolute kidney-sparing indications; 3) High-risk patients with renal insufficiency, or diseases that lead to renal insufficiency, have relative indications for kidney protection; 4) High-risk patients with good renal function, but a particularly strong willingness to preserve the kidney, willing to accept clinical studies and participate in kidney preservation. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year events-free survival rate
events-free survival defined as time from initiation of first protocol therapy until the first time to develop any local recurrence (local/bladder), distant metastases or any cause-related death.
Measured: Up to 2 years
Secondary outcomes (2)
Overall survival
defined as time from initiation for protocol therapy to death.
Measured: Up to 2 years
Metastasis free surviva
metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start23 Nov 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial Carcinoma Receiving Kidney-sparing TherapyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Tianjin Medical University Second Hospital, Xiangya Hospital of Central South University, West China Hospital, Ruijin Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of University of Science and Technology of China, The Second Hospital of Anhui Medical University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204406
- Sponsor's protocol ID
- LY2023-081-B
- Status last verified
- Jan 2024
- First submitted
- 26 Nov 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
- ClinicalTrials.gov ID
- NCT06204406
- Acronym / sponsor ID
- LY2023-081-B
- Keywords
- kidney-sparing therapy, upper tract urothelial carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Tianjin Medical University Second Hospital, Xiangya Hospital of Central South University, West China Hospital, Ruijin Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of University of Science and Technology of China, The Second Hospital of Anhui Medical University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jan 2024 (actual)
- 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.
Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is <50% for pT2/T3 and <10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.
Detailed description
The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy | – | Other: ObservationalThe enrolled patients were patients with limited-stage or locally advanced UTUC, who were classified into the following four categories according to the 2022 EAU guidelines as low-risk and high-risk: 1) low-risk patients who were willing to undergo kidney-sparing surgery directly; 2) High-risk patients, with solitary kidney, functional single kidney, bilateral tumors, and absolute kidney-sparing indications; 3) High-risk patients with renal insufficiency, or diseases that lead to renal insufficiency, have relative indications for kidney protection; 4) High-risk patients with good renal function, but a particularly strong willingness to preserve the kidney, willing to accept clinical studies and participate in kidney preservation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy
Key inclusion criteria (4 listed)
- Histopathological confirmed upper tract urothelial carcinoma;
- Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery;
- Participants must be willing to attend the follow-up visits;
- Sign informed consent.
Key exclusion criteria (3 listed)
- Unable to undergo kidney-sparing surgery;
- Life expectancy < 6 months;
- Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
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 |
|---|---|---|
| ObservationalThis is a prospective observational study with observation only and no intervention | Other | Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy |
Primary outcome
Two-year events-free survival rate
Time frame: Up to 2 years
events-free survival defined as time from initiation of first protocol therapy until the first time to develop any local recurrence (local/bladder), distant metastases or any cause-related death.
2 secondary outcomes
Overall survival
Time frame: Up to 2 years
Metastasis free surviva
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Not yet recruitingObservational study
Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma
Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy, Upper Tract Urothelial Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwei Huang, Dr (8613651682825, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year events-free survival rate (time frame: Up to 2 years). 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 12 Jan 2024.