ccRCCNCT06775574
Prognostic Significance of the Lung Immune Prognostic Index (LIPI) in Postoperative Clear Cell Renal Cell Carcinoma: a Multicenter Retrospective Cohort Study
An observational study of ccRCC, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy. Patients were stratified into the LIPI good group and the intermediate/poor (int./poor) group based on dNLR (≥ 3) and LDH (≥ 245 U/L) levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ccRCC
- How many people
- 704 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2014to 30 Sep 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy.
Who may be able to join
- Pathologically diagnosed with ccRCC;
- Underwent radical or partial nephrectomy.
Who cannot join
- presence of concurrent malignancies;
- missing data or failure to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy. Patients were stratified into the LIPI good group and the intermediate/poor (int./poor) group based on dNLR (≥ 3) and LDH (≥ 245 U/L) levels. Propensity score matching (PSM) was used to adjust for baseline differences and minimize selection bias. Kaplan-Meier survival curves and Cox regression models were employed to evaluate the impact of LIPI and other clinical factors on recurrence-free survival (RFS) and overall survival (OS).
- Conditions
- ccRCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with dNLR < 3 and LDH levels below the upper limit of normal | |
| Cohort 2 | Patients with dNLR ≥ 3 and LDH levels above the upper limit of normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: 5 years
recurrence-free survival (RFS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Nov 2014
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ccRCCStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Retrospective
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775574
- Sponsor's protocol ID
- 0361-01
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan Z, Li Y, Lou J, Shan S, Guo Y, Jiang S, He Q, Zhou G, Yang L. Preoperative lung immune prognostic index (LIPI) predicts postoperative outcomes in clear cell renal cell carcinoma: a multicenter study. Sci Rep. 2026 May 25;16(1):23900. doi: 10.1038/s41598-026-54219-3.
PubMed 42185427
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of the Lung Immune Prognostic Index (LIPI) in Postoperative Clear Cell Renal Cell Carcinoma: a Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06775574
- Acronym / sponsor ID
- 0361-01
- Conditions
- ccRCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Jan 2025 (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.
This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy. Patients were stratified into the LIPI good group and the intermediate/poor (int./poor) group based on dNLR (≥ 3) and LDH (≥ 245 U/L) levels. Propensity score matching (PSM) was used to adjust for baseline differences and minimize selection bias. Kaplan-Meier survival curves and Cox regression models were employed to evaluate the impact of LIPI and other clinical factors on recurrence-free survival (RFS) and overall survival (OS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with dNLR < 3 and LDH levels below the upper limit of normal |
| Cohort 2 | – | –Patients with dNLR ≥ 3 and LDH levels above the upper limit of normal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy.
Key inclusion criteria (2 listed)
- Pathologically diagnosed with ccRCC;
- Underwent radical or partial nephrectomy.
Key exclusion criteria (2 listed)
- presence of concurrent malignancies;
- missing data or failure to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival (OS)
Time frame: 5 years
recurrence-free survival (RFS)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 42185427Pan Z, Li Y, Lou J, Shan S, Guo Y, Jiang S, He Q, Zhou G, Yang L. Preoperative lung immune prognostic index (LIPI) predicts postoperative outcomes in clear cell renal cell carcinoma: a multicenter study. Sci Rep. 2026 May 25;16(1):23900. doi: 10.1038/s41598-026-54219-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ccRCC, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 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: finished, as of the sponsor's last update on 15 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall survival (OS) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775574, which also lists 1 linked publication.
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 15 Jan 2025.