Multicenter Retrospective Cohort of Pulmonary NUT Carcinoma

March 6, 2026 updated by: Three Gorges Hospital of Chongqing University

A Multicenter Retrospective Real-World Cohort Study of Pulmonary NUT Carcinoma With Integrated Clinical, Pathologic, and Imaging Analyses

This study is a multi-center, retrospective observational study of patients with lung NUT carcinoma. Existing clinical records from participating hospitals will be reviewed to describe patient characteristics, treatments, and outcomes. No study-related interventions will be performed. Data will be de-identified to protect patient privacy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, retrospective observational cohort study of lung NUT carcinoma. Eligible patients diagnosed with lung NUT carcinoma at participating hospitals will be identified based on pathology with supportive evidence of NUT immunohistochemistry (IHC) positivity and/or NUTM1 rearrangement/fusion. Data will be extracted from existing medical records and follow-up documentation, including demographics, tumor characteristics, staging, treatments, and outcomes. When available, routine-care pathology information and imaging data will be collected and de-identified.

Primary outcome: progression-free survival (PFS).

Secondary outcomes: overall survival (OS) and other routinely documented outcomes when available.

No new drugs, devices, procedures, or additional tests will be provided as part of this research. All data will be de-identified and stored with access controls according to applicable regulations and ethics approvals at each participating site.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 430000
        • Chongqing University Three Gorges Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pulmonary (lung) NUT carcinoma identified retrospectively from participating hospitals using pathology records, with clinical, pathologic, and imaging data abstracted from existing medical records and de-identified for analysis.

Description

Inclusion Criteria:

  • Pathologically confirmed pulmonary (lung) NUT carcinoma.
  • Evidence of NUT immunohistochemistry (IHC) positivity and/or NUTM1 rearrangement/fusion, per local pathology report.
  • Diagnosed and/or treated at a participating hospital during the study period.
  • Availability of sufficient medical record data to abstract key baseline characteristics, treatments, and outcomes.

Exclusion Criteria:

  • Primary tumor site not in the lung.
  • Records insufficient to confirm the diagnosis of pulmonary NUT carcinoma.
  • No follow-up or outcome information available after diagnosis (insufficient for survival/outcome assessment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From diagnosis through study completion (up to May 2026)
Time from initial diagnosis (index date) to first documented disease progression per routine clinical assessment or death from any cause, whichever occurs first.
From diagnosis through study completion (up to May 2026)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From diagnosis through study completion (up to May 2026)
Time from initial diagnosis (index date) to death from any cause.
From diagnosis through study completion (up to May 2026)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Three Gorges Hospital of Chongqing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNUT-RETRO-01
  • IRB-2026-9 (Other Identifier: Ethics Committee, Chongqing University Affiliated Three Gorges Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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